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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 K862726
Device Name DISPOSABLE SHOE COVERS AND NURSES CAPS
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Applicant Contact PIYUSH M SHAH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Correspondent Contact PIYUSH M SHAH
Regulation Number878.4040
Classification Product Code
FXP  
Date Received07/18/1986
Decision Date 08/01/1986
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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