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FDA 510(k) Application Details - K010356
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K010356
Device Name
Latex Patient Examination Glove
Applicant
ENZYMIC TECHNOLOGIES SDN BHD
AIR KEROH INDUSTRIAL ESTATE
MELAKA 75450 MY
Other 510(k) Applications for this Company
Contact
LEE HONG YEN
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
02/05/2001
Decision Date
03/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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