FDA 510(k) Application Details - K001432

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K001432
Device Name Vinyl Patient Examination Glove
Applicant SHANGHAI PM PLASTICS ENT. CO., LTD.
NO. 258, YUSHU RD. CHANGQIAO
TOWNSHIP, SHOHJIANG COUNTY, SH CN
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Contact CHANG T SUN
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 05/08/2000
Decision Date 07/05/2000
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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