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FDA 510(k) Application Details - K062313
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K062313
Device Name
Latex Patient Examination Glove
Applicant
PT. MAHAKARYA INTI BUANA
J1. SEI BELUMAI
DESA DALU 10 A DUSUN I
TANJUNG MORAWA, SUMUT 20362 ID
Other 510(k) Applications for this Company
Contact
VENUGOPAL NADARAJAN
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
08/08/2006
Decision Date
11/30/2006
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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