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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cover, barrier, protective
510(k) Number K032065
Device Name MEDLINE BAND BAGS AND EQUIPMENT COVERS
Applicant
MEDLINE INDUSTRIES, INC.
1170 S. NORTHPOINT BLVD.
WAUKEGAN,  IL  60085
Applicant Contact LARA N SIMMONS
Correspondent
MEDLINE INDUSTRIES, INC.
1170 S. NORTHPOINT BLVD.
WAUKEGAN,  IL  60085
Correspondent Contact LARA N SIMMONS
Regulation Number878.4370
Classification Product Code
MMP  
Date Received07/03/2003
Decision Date 09/22/2003
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
Recalls CDRH Recalls
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