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FDA 510(k) Application Details - K960277
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K960277
Device Name
Latex Patient Examination Glove
Applicant
HIGHACTIVE SDN. BHD.
LOT 12-B, INDUSTRIAL AREA,
6 1/2 MILES, JALAN KEPONG
KUALA LUMPUR 52000 MY
Other 510(k) Applications for this Company
Contact
CHONG YOON TAT
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
01/19/1996
Decision Date
05/15/1996
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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