The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Bipolar Coagulation Instrument.
| Device ID | K952161 |
| 510k Number | K952161 |
| Device Name: | BIPOLAR COAGULATION INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | John D Ferros |
| Correspondent | John D Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-07-05 |