FDA 510(k) Application Details - K982885

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K982885
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.
30798 US HWY 19 N
PALM HARBOR, FL 34684 US
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Contact DON MORRIS
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 08/17/1998
Decision Date 12/04/1998
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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