FDA 510(k) Application Details - K041379

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K041379
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG WALLY PLASTICS CO., LTD
NO 78 TONGDA RD.
JINZHOU CITY, HEBEI 052260 CN
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Contact IRIS YANG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 05/24/2004
Decision Date 08/31/2004
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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