The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Bipolar Coagulating Forceps.
Device ID | K811820 |
510k Number | K811820 |
Device Name: | BIPOLAR COAGULATING FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-29 |
Decision Date | 1981-07-28 |