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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 K032666
Device Name MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
Applicant
Medline Industries, Inc.
1170 S. Northpoint Blvd.
Waukegan,  IL  60085
Applicant Contact LARA SIMMONS
Correspondent
Medline Industries, Inc.
1170 S. Northpoint Blvd.
Waukegan,  IL  60085
Correspondent Contact LARA SIMMONS
Regulation Number878.4370
Classification Product Code
KKX  
Subsequent Product Code
FYA  
Date Received08/28/2003
Decision Date 03/16/2005
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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