The following data is part of a premarket notification filed by J. Aderer, Inc. with the FDA for Precious Metal Alloys.
Device ID | K821022 |
510k Number | K821022 |
Device Name: | PRECIOUS METAL ALLOYS |
Classification | Alloy, Other Noble Metal |
Applicant | J. ADERER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-13 |
Decision Date | 1982-05-10 |