The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Bair Hugger Model 675 Total Temperature Management System.
| Device ID | K171373 |
| 510k Number | K171373 |
| Device Name: | 3M Bair Hugger Model 675 Total Temperature Management System |
| Classification | System, Thermal Regulating |
| Applicant | 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
| Contact | Jon Platt |
| Correspondent | Jon Platt 3M Company 3M Center, Building 275-5W-06 St. Paul, MN 55144 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2017-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50707387783704 | K171373 | 000 |
| 50707387782103 | K171373 | 000 |
| 50707387774078 | K171373 | 000 |
| 50707387804072 | K171373 | 000 |
| 50707387803983 | K171373 | 000 |
| 50707387803945 | K171373 | 000 |