K885066 is an FDA 510(k) clearance for the HEMATOME SYSTEM. This device is classified as a Motor, Surgical Instrument, Pneumatic Powered (Class I - General Controls, product code GET).
Submitted by Surgical Dynamics, Inc. (San Leandro, US). The FDA issued a Cleared decision on May 1, 1989, 146 days after receiving the submission on December 6, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K885066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1988 |
| Decision Date | May 01, 1989 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GET — Motor, Surgical Instrument, Pneumatic Powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |