September 10, 2004
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Sudmo BAA S400 Flow Diversion Device, Model 2000 DN 1"- 4" inch
The Sudmo BAA S400 Flow Diversion Device, Model 2000 when constructed, installed and operated as described in this memorandum; has been found to meet the applicable provisions of the Grade "A" Pasteurized Milk Ordinance (PMO).
This piece of equipment is a dual stem Flow Diversion Device (FDD), which has been designed to comply with Item 16p (B) of the PMO. The technical designs submitted to FDA for review were for 1"- 4" inch FDDs.
FDA acceptance is based on compliance with the installation and operation criteria cited in Sudmo's Operations and Instructions Manual, Revision 13-August 8, 2004, and the following provisions:
- The control system utilized with the FDD shall comply with Appendix H. of the PMO and shall be found acceptable to the State Regulatory Agency.
- The installation shall comply with all applicable tests cited in Appendix I. of the PMO.
- Appendix I., Test 5.4, Device Assembly, of the PMO, shall be conducted in accordance with the testing procedures cited in the Operations and Instructions Manual, provided by the manufacturer. The manufacturer shall provide a spacer (0.059 inches/1.5mm wide) to facilitate conducting this test in the required manner.
- Upon proper installation and the determination of compliance through appropriate PMO testing, regulatory seals shall be applied through the handle of the manual air shut-off valves and around the valve body. The seal shall be sufficiently tight to assure that the manual shut-off valve cannot be closed without breaking the seal.
All technical information that was submitted and reviewed constitutes the Sudmo BAA S400 Flow Diversion Device Model 2000 DN 1"- 4" inch Engineering Design and Technical Construction File (EDTCF).
For additional information regarding this piece of equipment please contact:
1330 Anvil Drive,
Rockford, Il 61115
Phone: (815) - 639-0322
Fax: (815) - 639-1135
FDA's review and acceptance of this piece of equipment does not constitute FDA endorsement or approval of this piece of equipment. Any representation on a label or in printed literature citing or indicating as "FDA Approved" is false and misleading.
An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web Site at http://www.fda.gov/Food at a later date.
If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.
Jonathan M. Gardner
FDA/MSB Milk Sanitation Officer
Public Health Seal Placement
FDD Testing Procedure