K771399 is an FDA 510(k) clearance for the LIP & CHEEK RETRACTOR. This device is classified as a Retractor, All Types (Class I - General Controls, product code EIG).
Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1977, 28 days after receiving the submission on July 29, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K771399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1977 |
| Decision Date | August 26, 1977 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIG — Retractor, All Types |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |