The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Model 1860 Health Care Particulate Respirator Type N95.
| Device ID | K955382 |
| 510k Number | K955382 |
| Device Name: | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 |
| Classification | Mask, Surgical |
| Applicant | 3M COMPANY BUILDINGS 251-3 AND 270 St. Paul, MN 55144 -1000 |
| Contact | Dorothea Von Busch |
| Correspondent | Dorothea Von Busch 3M COMPANY BUILDINGS 251-3 AND 270 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 | 1995-11-24 |
| Decision Date | 1996-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387444124 | K955382 | 000 |
| 50707387419429 | K955382 | 000 |
| 50051131275541 | K955382 | 000 |
| 50051131275534 | K955382 | 000 |
| 58887719257409 | K955382 | 000 |
| 58887719257393 | K955382 | 000 |
| 50068060858127 | K955382 | 000 |
| 50068060856963 | K955382 | 000 |