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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K081464
Device Name STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
Applicant
Cardinalhealth
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact STEVE TAMSETT
Correspondent
Cardinalhealth
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact STEVE TAMSETT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/27/2008
Decision Date 08/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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