FDA 510(k) Application Details - K031142

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K031142
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
#1 BIYU RD., CANGQIAO TOWNSHIP
SONGJIANG SHANGHAI 201600 CN
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Contact DANNY WANG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 09/04/2003
Decision Date 03/17/2004
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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