The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for May Humerus Plates.
Device ID | K912936 |
510k Number | K912936 |
Device Name: | MAY HUMERUS PLATES |
Classification | Plate, Fixation, Bone |
Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Contact | Stuart |
Correspondent | Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-05 |
Decision Date | 1991-09-06 |