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GUIDANCE DOCUMENT

Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) May 1978

Final

Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The guidelines are intended as overall guides to the investigation of laparoscopic bipolar coagulators (and accessories). The place for specifics is in the individual product development protocols. Specific protocols will be evaluated and approved on their own  merits.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.