The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Modification Of Bair Hugger Patient Warming System.
| Device ID | K933726 |
| 510k Number | K933726 |
| Device Name: | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM |
| Classification | Warmer, Irrigation Solution |
| Applicant | AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Scott D Augustine |
| Correspondent | Scott D Augustine AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-02 |
| Decision Date | 1994-01-28 |