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 |