The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for C & B 61 Pentron C & B61.
| Device ID | K833289 |
| 510k Number | K833289 |
| Device Name: | C & B 61 PENTRON C & B61 |
| 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 | Yes |
| Date Received | 1983-09-22 |
| Decision Date | 1983-12-29 |