FDA 510(k) Application Details - K013026

Device Classification Name Latex Patient Examination Glove

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510(K) Number K013026
Device Name Latex Patient Examination Glove
Applicant GREAT GLOVE (THAILAND) CO. LTD.
180/3 M. 7 SRISONTHON RD.
T. SRISONTHON,
A. THALANG, PHUKET 83110 TH
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Contact KM LEE
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 09/10/2001
Decision Date 10/15/2001
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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