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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drape, surgical
510(k) Number K760867
Device Name STERILE STOCKINETTE
Applicant
ABCO DEALERS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ABCO DEALERS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/18/1976
Decision Date 11/03/1976
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
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