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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number890.5710
Classification Product Code
IMD  
Date Received09/24/1993
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
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