| Device Classification Name |
Pack, Hot Or Cold, Water Circulating
|
| 510(k) Number |
K871962 |
| Device Name |
HOT/ICE DUAL FUNCTION EQUIPMENT |
| Applicant |
| Thermo Temp, Inc. |
| 1923 Tampa E. Blvd. |
|
Tampa,
FL
33619
|
|
| Applicant Contact |
JAMES T WILSON |
| Correspondent |
| Thermo Temp, Inc. |
| 1923 Tampa E. Blvd. |
|
Tampa,
FL
33619
|
|
| Correspondent Contact |
JAMES T WILSON |
| Regulation Number | 890.5720 |
| Classification Product Code |
|
| Date Received | 05/20/1987 |
| Decision Date | 06/26/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|