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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K032223
Device Name COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH
Applicant
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Applicant Contact THOMAS J KARDOS
Correspondent
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Correspondent Contact THOMAS J KARDOS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/21/2003
Decision Date 10/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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