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FDA 510(k) Application Details - K954153
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K954153
Device Name
Vinyl Patient Examination Glove
Applicant
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
JL: K.H.MOH MANSYUR NO. 128
JAKARTA 11210 ID
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Contact
LINGA SUMARTA
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/1995
Decision Date
01/26/1996
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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