The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Cement Restrictor.
| Device ID | K942060 |
| 510k Number | K942060 |
| Device Name: | P.F.C. CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Sally L Maher |
| Correspondent | Sally L Maher JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-09-20 |