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FDA 510(k) Application Details - K964629
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K964629
Device Name
Vinyl Patient Examination Glove
Applicant
ARISTA MEDI PRIMA
JL. K. H. MOH MANSYUR 128
JAKARTA 11210 ID
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Contact
HADY SUYANTHO
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
11/19/1996
Decision Date
02/10/1997
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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