FDA 510(k) Application Details - K020918

Device Classification Name Surgeon'S Gloves

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510(K) Number K020918
Device Name Surgeon'S Gloves
Applicant ECI MEDICAL TECHNOLOGIES, INC.
2 COOK RD.
BRIDGEWATER, NOVA SCOTIA B4V 3W7 CA
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Contact SHIRANTHA SAMARAPPULI
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Regulation Number 878.4460

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Classification Product Code KGO
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Date Received 03/21/2002
Decision Date 04/19/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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