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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 K890852
Device Name AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
Applicant
Ati
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
Ati
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received02/21/1989
Decision Date 04/14/1989
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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