The following data is part of a premarket notification filed by Harvey A. Turner, M.d. with the FDA for Safe-t Arm Board.
Device ID | K830018 |
510k Number | K830018 |
Device Name: | SAFE-T ARM BOARD |
Classification | Board, Arm (with Cover), Sterile |
Applicant | HARVEY A. TURNER, M.D. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BTX |
CFR Regulation Number | 878.3910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-03 |
Decision Date | 1983-01-26 |