The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for C & B 40 Pentro C & B40.
Device ID | K833290 |
510k Number | K833290 |
Device Name: | C & B 40 PENTRO C & B40 |
Classification | Remover, Crown |
Applicant | GENESIS INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 | 1984-01-03 |