FDA 510(k) Application Details - K081907

Device Classification Name Latex Patient Examination Glove

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510(K) Number K081907
Device Name Latex Patient Examination Glove
Applicant SIAM SEMPERMED CORP. LTD.
13900 49TH STREET NORTH
CLEARWATER, FL 33762 US
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Contact WILLIAM E HARRIS
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 07/03/2008
Decision Date 09/03/2008
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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