The following data is part of a premarket notification filed by Infection Control Products, Inc. with the FDA for Agafar Face Shield.
| Device ID | K935779 |
| 510k Number | K935779 |
| Device Name: | AGAFAR FACE SHIELD |
| Classification | Accessory, Surgical Apparel |
| Applicant | INFECTION CONTROL PRODUCTS, INC. 696 MAIN ST. P.O. BOX 739 Gardendale, AL 35071 -0739 |
| Contact | John Patrick Russell |
| Correspondent | John Patrick Russell INFECTION CONTROL PRODUCTS, INC. 696 MAIN ST. P.O. BOX 739 Gardendale, AL 35071 -0739 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-03 |
| Decision Date | 1994-02-01 |