K903718 is an FDA 510(k) clearance for the OROSCOPE MODEL NUMBER COS-100. This device is classified as a Evacuator, Oral Cavity (Class I - General Controls, product code EHZ).
Submitted by Cygnus Instruments, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on November 9, 1990, 85 days after receiving the submission on August 16, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K903718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1990 |
| Decision Date | November 09, 1990 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EHZ — Evacuator, Oral Cavity |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |