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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 K820890
Device Name URETHANE ORTHOPAEDIC CASTING TAPE
Applicant
Hexcel Medical
SC 
Applicant Contact & NEPHEW
Correspondent
Hexcel Medical
SC 
Correspondent Contact & NEPHEW
Regulation Number890.3025
Classification Product Code
ITG  
Date Received03/30/1982
Decision Date 06/23/1982
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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