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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K061000
Device Name EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
Applicant
Cook Vascular, Inc.
1186 Montgomery Lane
Vandergrift,  PA  15690
Applicant Contact JIM FERGUSON, JR
Correspondent
Cook Vascular, Inc.
1186 Montgomery Lane
Vandergrift,  PA  15690
Correspondent Contact JIM FERGUSON, JR
Regulation Number870.1310
Classification Product Code
DRE  
Date Received04/11/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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