The following data is part of a premarket notification filed by United States Surgical with the FDA for Surgical Dynamics Ogden Suture Anchor With Suture.
| Device ID | K020352 |
| 510k Number | K020352 |
| Device Name: | SURGICAL DYNAMICS OGDEN SUTURE ANCHOR WITH SUTURE |
| Classification | Screw, Fixation, Bone |
| Applicant | UNITED STATES SURGICAL 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Tina Rideout |
| Correspondent | Tina Rideout UNITED STATES SURGICAL 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 | 2002-02-04 |
| Decision Date | 2002-02-26 |
| Summary: | summary |