FDA 510(k) Application Details - K024154

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K024154
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI HUAMAO GLOVES CO., LTD.
55 NORTHERN BLVD. SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 12/17/2002
Decision Date 01/06/2003
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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