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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K953997
Device Name ROTABLATOR ROTATIONAL ANGIOPLASTY
Applicant
HEART TECHNOLOGY MFG., INC.
17425 N.E. UNION HILL RD.
REDMOND,  WA  98052
Applicant Contact DIANE JOHNSON
Correspondent
HEART TECHNOLOGY MFG., INC.
17425 N.E. UNION HILL RD.
REDMOND,  WA  98052
Correspondent Contact DIANE JOHNSON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received08/24/1995
Decision Date 12/22/1995
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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