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 |