The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m 1830 Fluid Block Anti-fog Tie-on Surgical Mask And 3m 1830fs Fluid Block Anti-fog Tie-on Surgical Mask With Face Shie.
| Device ID | K965043 |
| 510k Number | K965043 |
| Device Name: | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE |
| Classification | Mask, Surgical |
| Applicant | MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
| Contact | Karen C Maass |
| Correspondent | Karen C Maass MINNESOTA MINING AND MFG. CO. 3M CENTER 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 | 1996-12-17 |
| Decision Date | 1997-03-10 |
| Summary: | summary |