The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Soft Tissue Suture Washer/3 Hole Washer.
| Device ID | K910229 |
| 510k Number | K910229 |
| Device Name: | SOFT TISSUE SUTURE WASHER/3 HOLE WASHER |
| Classification | Washer, Bolt Nut |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-07-24 |