FDA 510(k) Application Details - K031072

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K031072
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
18709 GREEN BAY DR.
ROWLAND HIGHS, CA 91748 US
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 04/04/2003
Decision Date 05/06/2003
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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