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FDA 510(k) Application Details - K990840
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K990840
Device Name
Polymer Patient Examination Glove
Applicant
TERANG NUSA SDN BHD
1 JALAN 8, PENGKALAN CHEPA 2
INDUSTRIAL ZONE,
KOTA BHARU, KELANTAN 16100 MY
Other 510(k) Applications for this Company
Contact
CHIN-GUAN LOW
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
03/15/1999
Decision Date
05/17/1999
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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