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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Shoe And Shoe Cover, Conductive
510(k) Number K831952
Device Name SURGICAL APPAREL SHOE COVERS
Applicant
SUDRECA SURGICAL DRESSINGS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SUDRECA SURGICAL DRESSINGS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4040
Classification Product Code
BWP  
Date Received06/15/1983
Decision Date 07/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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