FDA 510(k) Application Details - K983893

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K983893
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG BRETHERN PLASTIC CO.,LTD.
NO. 37 ZHONGHUA SOUTH ST.
SHIJIAZHUANG, HEBEI CN
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Contact XIN-LAI ZHOU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 11/02/1998
Decision Date 06/21/1999
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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