The following data is part of a premarket notification filed by Burke, Inc. with the FDA for Concept Model 5200 Thermal Therapy System.
| Device ID | K911943 |
| 510k Number | K911943 |
| Device Name: | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BURKE, INC. 11701 S. BELCHER ROAD, SUITE 119 Largo, FL 34643 |
| Contact | Robert E Burke |
| Correspondent | Robert E Burke BURKE, INC. 11701 S. BELCHER ROAD, SUITE 119 Largo, FL 34643 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-07-19 |