The following data is part of a premarket notification filed by Mid America Medical, Inc. with the FDA for Fluid Resistant Mask With Wrap Around Eye Shield.
| Device ID | K934974 |
| 510k Number | K934974 |
| Device Name: | FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD |
| Classification | Mask, Surgical |
| Applicant | MID AMERICA MEDICAL, INC. 411 GARRARD ST. Covington, KY 41011 |
| Contact | Todd V Mcmurtry |
| Correspondent | Todd V Mcmurtry MID AMERICA MEDICAL, INC. 411 GARRARD ST. Covington, KY 41011 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-19 |
| Decision Date | 1994-04-13 |