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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K982694
Device Name MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact LARA N SIMMONS
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact LARA N SIMMONS
Regulation Number878.4040
Classification Product Code
FYA  
Subsequent Product Code
KKX  
Date Received08/03/1998
Decision Date 12/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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