The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Cement Pressurizing System.
| Device ID | K943906 |
| 510k Number | K943906 |
| Device Name: | P.F.C. CEMENT PRESSURIZING SYSTEM |
| Classification | Dispenser, Cement |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ORTHOPEDIC DIVISION 325 PARAMOUNT DRIVE Raynham, MA 02767 -0350 |
| Contact | John D Ferros |
| Correspondent | John D Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. ORTHOPEDIC DIVISION 325 PARAMOUNT DRIVE Raynham, MA 02767 -0350 |
| Product Code | KIH |
| CFR Regulation Number | 888.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-11 |
| Decision Date | 1994-12-21 |