FDA 510(k) Application Details - K022087

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K022087
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD.
268 YUSHU RD., CANGQIAO
TOWNSHIP, SONGJIANG COUNTY
SHANGHAI 201600 CN
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Contact PETER WANG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 06/27/2002
Decision Date 07/11/2002
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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