The following data is part of a premarket notification filed by Accu-speed, Incorporated with the FDA for Soft Tissue Anchoring Washers.
| Device ID | K030031 |
| 510k Number | K030031 |
| Device Name: | SOFT TISSUE ANCHORING WASHERS |
| Classification | Retention Device, Suture |
| Applicant | ACCU-SPEED, INCORPORATED P.O. BOX 1008, 65 GAY RD. Groton, MA 01450 |
| Contact | Robert W Secovich |
| Correspondent | Robert W Secovich ACCU-SPEED, INCORPORATED P.O. BOX 1008, 65 GAY RD. Groton, MA 01450 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-03 |
| Decision Date | 2003-01-28 |