The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Disposable Bipolar Coagulating Forceps.
Device ID | K900533 |
510k Number | K900533 |
Device Name: | DISPOSABLE BIPOLAR COAGULATING FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
Contact | Richard M Beane |
Correspondent | Richard M Beane KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-23 |
Decision Date | 1990-04-09 |