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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 K964142
Device Name MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060 -4486
Applicant Contact CHRISTINE GALEA
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060 -4486
Correspondent Contact CHRISTINE GALEA
Regulation Number878.4370
Classification Product Code
KKX  
Subsequent Product Code
FYA  
Date Received10/16/1996
Decision Date 02/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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