FDA 510(k) Application Details - K032223

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K032223
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant COOK VASCULAR, INC.
RT. 66, RIVER RD.
P.O. BOX 529
LEECHBURG, PA 15656-0529 US
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Contact THOMAS J KARDOS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/21/2003
Decision Date 10/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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