FDA 510(k) Application Details - K014110

Device Classification Name Latex Patient Examination Glove

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510(K) Number K014110
Device Name Latex Patient Examination Glove
Applicant SIAM SEMPERMED CORP. LTD.
1308 MORNINGSIDE PARK DR.
ALPHARETTA, GA 30022 US
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Contact JAY MANSOUR
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 12/14/2001
Decision Date 02/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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