FDA 510(k) Application Details - K001837

Device Classification Name Polymer Patient Examination Glove

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510(K) Number K001837
Device Name Polymer Patient Examination Glove
Applicant SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
198 AVENUE DE LA D'EMERALD
SPARKS, NV 89434-9550 US
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Contact JANNA P TUCKER
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Regulation Number 880.6250

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Classification Product Code LZA
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Date Received 06/16/2000
Decision Date 07/11/2000
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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