FDA 510(k) Application Details - K023452

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K023452
Device Name Vinyl Patient Examination Glove
Applicant CANOPUS MEDICAL SUPPLY CO., LTD.
201 FU-HSING NORTH RD., 10TH
FL.
TAIPEI 105 TW
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Contact RUBY LIN
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 10/15/2002
Decision Date 11/20/2003
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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