FDA 510(k) Application Details - K990710

Device Classification Name Surgeon'S Gloves

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510(K) Number K990710
Device Name Surgeon'S Gloves
Applicant BARRIERMED GLOVE CO.
2500 WEST LAKE MARY BLVD.
LAKE MARY, FL 32746 US
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Contact CARLO PONCIPE
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 03/04/1999
Decision Date 05/20/1999
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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