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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K872797
Device Name NON-SKID SHOE COVERS
Applicant
Abco Dealers, Inc.
6601 W. Mill Rd.
P.O. Box 23090
Milwaukee,  WI  53218
Applicant Contact MOLLY PRIBEK
Correspondent
Abco Dealers, Inc.
6601 W. Mill Rd.
P.O. Box 23090
Milwaukee,  WI  53218
Correspondent Contact MOLLY PRIBEK
Regulation Number878.4040
Classification Product Code
FXP  
Date Received07/15/1987
Decision Date 08/04/1987
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
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