FDA 510(k) Application Details - K961602

Device Classification Name Latex Patient Examination Glove

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510(K) Number K961602
Device Name Latex Patient Examination Glove
Applicant SIAM SEMPERMED CORP. LTD.
14 LEEWARD ISLAND
CLEARWATER, FL 34630 US
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Contact DON MORRIS
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Regulation Number 880.6250

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Classification Product Code LYY
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Date Received 04/04/1996
Decision Date 10/07/1996
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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