The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m™ Vflex™ Health Care Particulate Respirator And Surgical Mask , Models 1804/1804s.
| Device ID | K171116 |
| 510k Number | K171116 |
| Device Name: | 3M™ VFlex™ Health Care Particulate Respirator And Surgical Mask , Models 1804/1804S |
| Classification | Respirator, Surgical |
| Applicant | 3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, MN 55144 |
| Contact | Linda Johnsen |
| Correspondent | Linda Johnsen 3M Health Care 3M Center, 2510 Conway Ave., Building 275-5W-06 St. Paul, MN 55144 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-14 |
| Decision Date | 2017-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30051131275936 | K171116 | 000 |
| 30051131275929 | K171116 | 000 |