The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Surgical Dynamics Pop Rivet.
| Device ID | K961585 |
| 510k Number | K961585 |
| Device Name: | SURGICAL DYNAMICS POP RIVET |
| Classification | Staple, Fixation, Bone |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-07-10 |
| Summary: | summary |