The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for T-pump, Temperature - Therapy Pump.
| Device ID | K760804 |
| 510k Number | K760804 |
| Device Name: | T-PUMP, TEMPERATURE - THERAPY PUMP |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | GAYMAR INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-12 |
| Decision Date | 1976-10-15 |