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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K040108
Device Name OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
Applicant
Est International Corporation
7668 Belpine Place
Rancho Cucamonga,  CA  91730
Applicant Contact ELIZABETH DENG
Correspondent
Est International Corporation
7668 Belpine Place
Rancho Cucamonga,  CA  91730
Correspondent Contact ELIZABETH DENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received01/20/2004
Decision Date 08/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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