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 |