FDA 510(k) Application Details - K102099

Device Classification Name Vinyl Patient Examination Glove

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510(K) Number K102099
Device Name Vinyl Patient Examination Glove
Applicant HONG DI PLASTIC PRODUCTS CO, LTD.
3973 SCHAEFER AVE.
CHINO, CA 91710 US
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Contact KATHY LIU
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Regulation Number 880.6250

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Classification Product Code LYZ
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Date Received 07/27/2010
Decision Date 10/06/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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