K935779 is an FDA 510(k) clearance for the AGAFAR FACE SHIELD. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by Infection Control Products, Inc. (Gardendale, US). The FDA issued a Cleared decision on February 1, 1994, 60 days after receiving the submission on December 3, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K935779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1993 |
| Decision Date | February 01, 1994 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |