K802646 is an FDA 510(k) clearance for the HAND PERCUSSOR CUP #65210. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980, 19 days after receiving the submission on October 24, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K802646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 1980 |
| Decision Date | November 12, 1980 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYI — Percussor, Powered-electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |