FDA 510(k) Application Details - K052772

Device Classification Name Surgeon'S Gloves

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510(K) Number K052772
Device Name Surgeon'S Gloves
Applicant BARRIERMED GLOVE CO.
155 TECHNOLOGY PARK
LAKE MARY, FL 32746 US
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Contact VICTOR J RAGUCCI
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 10/03/2005
Decision Date 12/20/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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