The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Surgical Mask With Face Sheild.
| Device ID | K940707 |
| 510k Number | K940707 |
| Device Name: | 3M SURGICAL MASK WITH FACE SHEILD |
| Classification | Mask, Surgical |
| Applicant | 3M COMPANY 3M MEDICAL PRODUCTS GROUP 3M CENTER/275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Marvin L Hart |
| Correspondent | Marvin L Hart 3M COMPANY 3M MEDICAL PRODUCTS GROUP 3M CENTER/275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-17 |
| Decision Date | 1994-05-23 |