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FDA 510(k) Application Details - K041848
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K041848
Device Name
Polymer Patient Examination Glove
Applicant
PT. SMART GLOVE INDONESIA
KAWASAN INDUSTRI MEDAN STAR JL
RAYA MEDAN-LUBUK PAKAM KM.19
TG MORAWA-DELI SERDANG 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
07/08/2004
Decision Date
08/20/2004
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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