The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Mirror Finish Bipolar Forceps.
| Device ID | K963499 |
| 510k Number | K963499 |
| Device Name: | MIRROR FINISH BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Jennifer L Morse |
| Correspondent | Jennifer L Morse JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-10-08 |
| Summary: | summary |