The following data is part of a premarket notification filed by Techstyles with the FDA for Thermuff Bag.
| Device ID | K920153 |
| 510k Number | K920153 |
| Device Name: | THERMUFF BAG |
| Classification | Instrument, Surgical, Disposable |
| Applicant | TECHSTYLES 6600 LBJ FREEWAY #4145 Dallas, TX 75240 |
| Contact | Winfield Singletary |
| Correspondent | Winfield Singletary TECHSTYLES 6600 LBJ FREEWAY #4145 Dallas, TX 75240 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1992-07-01 |