The following data is part of a premarket notification filed by Laerdal California, Inc. with the FDA for Stifnick Immobilizing Collar.
Device ID | K832990 |
510k Number | K832990 |
Device Name: | STIFNICK IMMOBILIZING COLLAR |
Classification | Orthosis, Cervical |
Applicant | LAERDAL CALIFORNIA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IQK |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-01 |
Decision Date | 1983-11-07 |