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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K820692
Device Name BANDBAG, WRAP, STERILE
Applicant
CONTOUR FABRICATORS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CONTOUR FABRICATORS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4370
Classification Product Code
MMP  
Date Received03/12/1982
Decision Date 05/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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