FDA 510(k) Application Details - K032071

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K032071
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.
30798 US HWY. 19N
PALM HARBOR, FL 34684 US
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Contact WILLIAM E HARRIS
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 07/03/2003
Decision Date 10/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party Y
Expedited Review



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