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FDA 510(k) Application Details - K123819
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K123819
Device Name
Latex Patient Examination Glove
Applicant
TOP CALIBRE SDN BHD
1-1,2 JALAN SETIA PRIMA U13/S
SETIA ALAM, SEKSYEN U13
SHAH ALAM, SELANGOR 40170 MY
Other 510(k) Applications for this Company
Contact
ROSNITA MAODIN
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2012
Decision Date
03/05/2013
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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