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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 K761254
Device Name BAND-AGE ICE-BANDAGE
Applicant
Surgicot, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Surgicot, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5720
Classification Product Code
ILO  
Date Received12/13/1976
Decision Date 02/24/1977
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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