K822711 is an FDA 510(k) clearance for the ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL. This device is classified as a Bougie, Urological (Class I - General Controls, product code FAX).
Submitted by Parker Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on November 3, 1982, 57 days after receiving the submission on September 7, 1982.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5520.
| 510(k) Number | K822711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1982 |
| Decision Date | November 03, 1982 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAX — Bougie, Urological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5520 |