Docket Management
Docket: 98N-1215 - Foreign Establishment Registration and Listing
Comment Number: EC -11

Accepted - Volume 2

Comment Record
Commentor Mr. Peter Engstrom Date/Time 2002-05-12 18:33:21
Organization Product Planning Associates
Category Individual

Comments for FDA General
Questions
1. General Comments Ladies/Gentlemen: Would you please let me know if this registration requirement applies only to drugs and their related dispensing apparatus? Or does it also apply to the importation of electromechanical components (e.g. switches, relays, et al) that are used in the production of medical equipment such as electro-surgical generators, x-ray tables, surgical microscopes, dental chairs and the like? I look forward to receiving your response. Thank you for your attention. Sincerely, Peter Engstrom




EC -11