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FDA 510(k) Application Details - K083156
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K083156
Device Name
Polymer Patient Examination Glove
Applicant
GIGA-DRIVE SDN, BHD
17A JALAN DATO HAJI MEGAT KHAS
TAMAN BANDAR UTAMA
IPOH, PERAK 31400 MY
Other 510(k) Applications for this Company
Contact
IAN NG TZE CHEU
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2008
Decision Date
05/08/2009
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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