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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K952064
Device Name FOCUS BALLOON DILATATION CATHETER
Applicant
CARDIOVASCULAR DYNAMICS, INC.
13844 ALTON PKWY.
SUITE 140
IRVINE,  CA  92718
Applicant Contact MICHAEL CROCKER
Correspondent
CARDIOVASCULAR DYNAMICS, INC.
13844 ALTON PKWY.
SUITE 140
IRVINE,  CA  92718
Correspondent Contact MICHAEL CROCKER
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/02/1995
Decision Date 06/21/1995
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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