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FDA 510(k) Application Details - K113790
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K113790
Device Name
Vinyl Patient Examination Glove
Applicant
FULL SYNERGY MEDICAL PRODUCTS INC
5748 EAGLEWOOD PLACE
RANCHO CUCAMONGA, CA 91739 US
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Contact
ELIZABTEH DENG
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
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More FDA Info for this Product Code
Date Received
12/23/2011
Decision Date
03/06/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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