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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 K993170
Device Name MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
Applicant
Medline Industries, Inc.
1170 Northpoint Blvd.
Waukegan,  IL  60085
Applicant Contact BETTY A LOCK
Correspondent
Medline Industries, Inc.
1170 Northpoint Blvd.
Waukegan,  IL  60085
Correspondent Contact BETTY A LOCK
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/22/1999
Decision Date 03/02/2000
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 No
Predetermined Change
Control Plan Authorized		 No
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