The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Bair Hugger Universal Warming Gown Made With Thinsulate Insulation.
| Device ID | K210605 |
| 510k Number | K210605 |
| Device Name: | 3M Bair Hugger Universal Warming Gown Made With Thinsulate Insulation |
| Classification | System, Thermal Regulating |
| Applicant | 3M Company 2510 Conway Ave. St. Paul, MN 55144 |
| Contact | Hilary Hovde |
| Correspondent | Hilary Hovde 3M Company 2510 Conway Ave. 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 | 2021-03-01 |
| Decision Date | 2021-04-29 |