The following data is part of a premarket notification filed by J. Aderer, Inc. with the FDA for Sr-algicap.
Device ID | K811867 |
510k Number | K811867 |
Device Name: | SR-ALGICAP |
Classification | Material, Impression |
Applicant | J. ADERER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-10-02 |