The following data is part of a premarket notification filed by E.m. Adams with the FDA for Thyroid Protective Collar.
Device ID | K832602 |
510k Number | K832602 |
Device Name: | THYROID PROTECTIVE COLLAR |
Classification | Apron, Leaded |
Applicant | E.M. ADAMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAJ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-02 |
Decision Date | 1983-09-29 |