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FDA 510(k) Application Details - K103770
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K103770
Device Name
Polymer Patient Examination Glove
Applicant
SYNTEX HEALTHCARE PRODUCTS CO., LTD
3973 SCHAEFER AVE
CHINO, CA 91710 US
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Contact
KATHY LIU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
12/27/2010
Decision Date
04/21/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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