FDA 510(k) Application Details - K023236

Device Classification Name Surgeon'S Gloves

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510(K) Number K023236
Device Name Surgeon'S Gloves
Applicant MAXXIM MEDICAL
308 CHURCH ST
HONEA PATH, SC 29654 US
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Contact ROY E MOSER
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 09/27/2002
Decision Date 11/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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