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FDA 510(k) Application Details - K020838
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K020838
Device Name
Latex Patient Examination Glove
Applicant
AR ALLIANCE HEALTHCARE SDN. BHD.
8, LORONG INDUSTRI 11, KAWASAN
PERINDUSTRIAN BUKIT PANCHOR,
NIBONG TEBAL, PULAU PINANG 14300 MY
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Contact
CHAU CHOON CHUAN
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
03/14/2002
Decision Date
04/23/2002
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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