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FDA 510(k) Application Details - K022814
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K022814
Device Name
Polymer Patient Examination Glove
Applicant
PT. SMART GLOVE INDONESIA
KAWASAN INDUSTRI MEDAN STAR J1
RAYA MEDAN-LUBUK PAKAM KM.19
TG MORAWA-DELI SERDANG UTARA 20362 ID
Other 510(k) Applications for this Company
Contact
FOO KHON PU
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
08/26/2002
Decision Date
02/19/2003
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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