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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 K925677
Device Name AUTOCHILL ACCESSORY KIT
Applicant
Aircast, Inc.
P.O. Box 709
92 River Rd.
Summit,  NJ  07902
Applicant Contact GLENN W JOHNSON
Correspondent
Aircast, Inc.
P.O. Box 709
92 River Rd.
Summit,  NJ  07902
Correspondent Contact GLENN W JOHNSON
Regulation Number890.5720
Classification Product Code
ILO  
Date Received07/16/1992
Decision Date 04/14/1993
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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