K834366 is an FDA 510(k) clearance for the SURGICAL INSTRUMENTS & ACCESSORIES. This device is classified as a Forceps, Rongeur, Surgical (Class I - General Controls, product code EMH).
Submitted by C.B.S. Biotechnics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984, 123 days after receiving the submission on October 27, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K834366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1983 |
| Decision Date | February 27, 1984 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMH — Forceps, Rongeur, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |