FDA 510(k) Application Details - K092681

Device Classification Name Latex Patient Examination Glove

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510(K) Number K092681
Device Name Latex Patient Examination Glove
Applicant KHAI HOAN JOINT STOCK COMPANY
CAU SAT HAMPLET, LAI HUNG
COMMUNE, BEN CAT DISTRICT
BINH DUONG PROVINCE VN
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Contact PHAM N THANH
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 09/01/2009
Decision Date 02/23/2010
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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