The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Bipolar Suction Coagulator.
| Device ID | K960455 |
| 510k Number | K960455 |
| Device Name: | BIPOLAR SUCTION COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 EAST WATER ST., BOX 545 Rockland, MA 02370 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 83 EAST WATER ST., 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 | 1996-01-30 |
| Decision Date | 1996-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841019113442 | K960455 | 000 |
| 20841019101081 | K960455 | 000 |
| 20841019101098 | K960455 | 000 |
| 20841019101104 | K960455 | 000 |
| 20841019101111 | K960455 | 000 |
| 20841019101128 | K960455 | 000 |
| 20841019101135 | K960455 | 000 |
| 20841019101142 | K960455 | 000 |
| 20841019101159 | K960455 | 000 |
| 20841019101166 | K960455 | 000 |
| 20841019101173 | K960455 | 000 |
| 20841019113343 | K960455 | 000 |
| 20841019113367 | K960455 | 000 |
| 20841019113374 | K960455 | 000 |
| 20841019113381 | K960455 | 000 |
| 20841019113411 | K960455 | 000 |
| 20841019113428 | K960455 | 000 |
| 20841019113435 | K960455 | 000 |
| 20841019101074 | K960455 | 000 |