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FDA 510(k) Application Details - K083908
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K083908
Device Name
Polymer Patient Examination Glove
Applicant
INNOVATIVE GLOVES CO; LTD
830 MOO 4 SANAMBIN-BANKLANG RD
TAMBON KUANLANG, AMPHUR HATYAI
SONGKHLA 90110 TH
Other 510(k) Applications for this Company
Contact
RAJEEV K SOOD
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZA
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More FDA Info for this Product Code
Date Received
12/30/2008
Decision Date
03/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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