The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Makar Full And Half Face Shield.
| Device ID | K942828 |
| 510k Number | K942828 |
| Device Name: | MAKAR FULL AND HALF FACE SHIELD |
| Classification | Accessory, Surgical Apparel |
| Applicant | INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Contact | Jeannie M Cleary |
| Correspondent | Jeannie M Cleary INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1995-02-23 |