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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 K944971
Device Name INCARE HOT/ICE COLD THERAPY COOLER
Applicant
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Applicant Contact JOSEPH S TOKARZ
Correspondent
Hollister, Inc.
2000 Hollister Dr.
Libertyville,  IL  60048
Correspondent Contact JOSEPH S TOKARZ
Regulation Number890.5720
Classification Product Code
ILO  
Date Received10/11/1994
Decision Date 01/30/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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