K873960 is an FDA 510(k) clearance for the LEWIS SAFE SLEEVE. This device is classified as a Accessories, Retractor, Dental (Class I - General Controls, product code EIF).
Submitted by Cheri Lewis, D.D.S. (Beverly Hills, US). The FDA issued a Cleared decision on December 4, 1987, 67 days after receiving the submission on September 28, 1987.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K873960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1987 |
| Decision Date | December 04, 1987 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIF — Accessories, Retractor, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |