The following data is part of a premarket notification filed by Thermotek, Inc. with the FDA for T-350 Therapeutic Cooling Machine.
| Device ID | K950711 |
| 510k Number | K950711 |
| Device Name: | T-350 THERAPEUTIC COOLING MACHINE |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | THERMOTEK, INC. 3330 EARHART DR. BLDG. 212 Carrollton, TX 75006 |
| Contact | John F Skinner |
| Correspondent | John F Skinner THERMOTEK, INC. 3330 EARHART DR. BLDG. 212 Carrollton, TX 75006 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-14 |
| Decision Date | 1995-07-06 |