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 |