The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for J-fx Cerclage System.
| Device ID | K971682 |
| 510k Number | K971682 |
| Device Name: | J-FX CERCLAGE SYSTEM |
| Classification | Wire, Surgical |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | John Ferros |
| Correspondent | John Ferros JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | LRN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1997-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295067740 | K971682 | 000 |