The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Sarmiento Forearm Nail.
Device ID | K871814 |
510k Number | K871814 |
Device Name: | SARMIENTO FOREARM NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Wayne L Nethercutt |
Correspondent | Wayne L Nethercutt DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-11 |
Decision Date | 1987-06-30 |