The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Cct-5200, Thermal Therapy System.
| Device ID | K884255 |
| 510k Number | K884255 |
| Device Name: | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller CONCEPT, INC. 11311 CONCEPT BLVD. 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 | 1988-10-11 |
| Decision Date | 1988-11-08 |