The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Suture Anchor.
| Device ID | K961578 |
| 510k Number | K961578 |
| Device Name: | SUTURE ANCHOR |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521181625 | K961578 | 000 |
| 10884521174610 | K961578 | 000 |
| 10884521176881 | K961578 | 000 |
| 10884521176898 | K961578 | 000 |
| 10884521176874 | K961578 | 000 |
| 10884521177031 | K961578 | 000 |
| 10884521176904 | K961578 | 000 |
| 10884521176935 | K961578 | 000 |
| 10884521176942 | K961578 | 000 |
| 10884521176966 | K961578 | 000 |
| 10884521177024 | K961578 | 000 |
| 10884521176959 | K961578 | 000 |