FDA 510(k) Application Details - K013753

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K013753
Device Name Vinyl Patient Examination Glove
Applicant CANOPUS MEDICAL SUPPLY CO., LTD.
13808 MAGNOLIA AVE.
CHINO, CA 91710 US
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Contact ELIZABETH DENG
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 11/13/2001
Decision Date 12/10/2001
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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