The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Bipolar Pencil Coagulator.
| Device ID | K962678 |
| 510k Number | K962678 |
| Device Name: | BIPOLAR PENCIL COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 EAST WATER ST. Rockland, MA 02370 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 83 EAST WATER ST. 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 | 1996-07-10 |
| Decision Date | 1996-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019104262 | K962678 | 000 |
| 00841019104255 | K962678 | 000 |