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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K950813
Device Name MOLLRING CUTTER
Applicant
Cardio Vascular Concepts, Inc.
3260 Alpine Rd.
Portola Valley,  CA  94028
Applicant Contact JAY LENKER
Correspondent
Cardio Vascular Concepts, Inc.
3260 Alpine Rd.
Portola Valley,  CA  94028
Correspondent Contact JAY LENKER
Regulation Number870.4875
Classification Product Code
DWX  
Date Received02/22/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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