FDA 510(k) Application Details - K022600

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K022600
Device Name Vinyl Patient Examination Glove
Applicant SHIJIAZHUANG WALLY PLASTICS CO., LTD
1202 S. RTE 31
MC HENRY, IL 60050 US
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Contact ANTONIO L GIACCIO
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 08/05/2002
Decision Date 09/16/2002
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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