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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 K875108
Device Name ACS CORONARY ANGIOSCOPIC CATHETER
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MICHAEL C KOLBER
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MICHAEL C KOLBER
Regulation Number876.1500
Classification Product Code
LYK  
Date Received12/14/1987
Decision Date 09/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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