The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Bray Rongeur.
| Device ID | K954699 |
| 510k Number | K954699 |
| Device Name: | BRAY RONGEUR |
| Classification | Rongeur, Manual |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-12 |
| Decision Date | 1995-12-06 |