The following data is part of a premarket notification filed by Teknar, Inc. with the FDA for Axisonic Ii.
Device ID | K810697 |
510k Number | K810697 |
Device Name: | AXISONIC II |
Classification | Cap, Cervical |
Applicant | TEKNAR, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HDR |
CFR Regulation Number | 884.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-16 |
Decision Date | 1981-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AXISONIC II 73423904 1285924 Dead/Cancelled |
Teknar, Inc. 1983-05-02 |