The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Pfc Cement Restrictor.
| Device ID | K951934 |
| 510k Number | K951934 |
| Device Name: | PFC CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| 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 | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-25 |
| Decision Date | 1995-05-16 |