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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Angioscope
510(k) Number K050808
Device Name CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
Applicant
Cardio-Optics, Inc.
2477 55th St., Suite 120
Boulder,  CO  80301
Applicant Contact LARRY BLANKENSHIP
Correspondent
Cardio-Optics, Inc.
2477 55th St., Suite 120
Boulder,  CO  80301
Correspondent Contact LARRY BLANKENSHIP
Regulation Number876.1500
Classification Product Code
LYK  
Date Received03/30/2005
Decision Date 07/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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