The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Bipolar Suction Coagulator.
| Device ID | K965241 |
| 510k Number | K965241 |
| Device Name: | BIPOLAR SUCTION COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. Marshfield, MA 02050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-02-28 |
| Summary: | summary |