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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, Water Circulating
510(k) Number K891092
Device Name TEMPTEK 5010 THERMAL COOLING BLANKET
Applicant
TEMPTEK, INC.
2741 SATSUMA #102
DALLAS,  TX  75229
Applicant Contact JOHN F SKINNER
Correspondent
TEMPTEK, INC.
2741 SATSUMA #102
DALLAS,  TX  75229
Correspondent Contact JOHN F SKINNER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received03/02/1989
Decision Date 05/26/1989
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
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