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 Meniscal Staple.
| Device ID | K013890 |
| 510k Number | K013890 |
| Device Name: | SURGICAL DYNAMICS MENISCAL STAPLE |
| Classification | Screw, Fixation, Bone |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Jennifer Schuck |
| Correspondent | Jennifer Schuck UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2001-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521176836 | K013890 | 000 |
| 10884521176829 | K013890 | 000 |
| 10884521176812 | K013890 | 000 |