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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 K113722
Device Name DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
Applicant
FULL SYNERGY MEDICAL PRODUCTS INC
5748 EAGLEWOOD PLACE
RANCHO CUCAMONGA,  CA  91739
Applicant Contact ELIZABETH DENG
Correspondent
FULL SYNERGY MEDICAL PRODUCTS INC
5748 EAGLEWOOD PLACE
RANCHO CUCAMONGA,  CA  91739
Correspondent Contact ELIZABETH DENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/19/2011
Decision Date 02/14/2012
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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