FDA 510(k) Application Details - K982720

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K982720
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD.
NO. 135 XIN-HUA WEST RD.
SHIJIAZHUANG 050081 CN
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Contact LIN CHIN YU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 08/04/1998
Decision Date 11/05/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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