The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for C & B57 Pentron C & B57.
Device ID | K833288 |
510k Number | K833288 |
Device Name: | C & B57 PENTRON C & B57 |
Classification | Remover, Crown |
Applicant | GENESIS INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EIS |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-22 |
Decision Date | 1983-12-20 |