Device Classification Name |
pack, hot or cold, disposable
|
510(k) Number |
K934631 |
Device Name |
TRANSWARMER |
Applicant |
PRISM TECHNOLOGIES, INC. |
7492 REINDEER TRAIL |
SAN ANTONIO,
TX
78238
|
|
Applicant Contact |
MERLE M SMITH |
Correspondent |
PRISM TECHNOLOGIES, INC. |
7492 REINDEER TRAIL |
SAN ANTONIO,
TX
78238
|
|
Correspondent Contact |
MERLE M SMITH |
Regulation Number | 890.5710
|
Classification Product Code |
|
Date Received | 09/24/1993 |
Decision Date | 02/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|