FDA 510(k) Application Details - K040532

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K040532
Device Name Vinyl Patient Examination Glove
Applicant ZI BO HONG WANG PLASTIC & RUBBER PRODUCTS CO. LTD.
17A STERLING ROAD
NORTH BILLERICA, MA 01862 US
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Contact HUAN-CHUNG LI
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 03/01/2004
Decision Date 03/23/2004
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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