K993255 is an FDA 510(k) clearance for the BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on December 6, 1999, 69 days after receiving the submission on September 28, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K993255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1999 |
| Decision Date | December 06, 1999 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |