The following data is part of a premarket notification filed by Richard F. Kronner, M.d. with the FDA for Adjustable Arm Support.
Device ID | K770065 |
510k Number | K770065 |
Device Name: | ADJUSTABLE ARM SUPPORT |
Classification | Support, Arm |
Applicant | RICHARD F. KRONNER, M.D. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IOY |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-01-12 |
Decision Date | 1977-02-02 |