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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Cast
510(k) Number K813219
Device Name CARAFLEX ELASTIC POLYMER PLASTER BANDA
Applicant
Carapace, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Carapace, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
ITG  
Date Received11/09/1981
Decision Date 12/17/1981
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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