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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 K993648
Device Name ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
Applicant
Boston Scientific Corporation Northwest Technology
17425 NE Union Hill Rd.
Redmond,  WA  98052
Applicant Contact CYNDY ADAMS
Correspondent
Boston Scientific Corporation Northwest Technology
17425 NE Union Hill Rd.
Redmond,  WA  98052
Correspondent Contact CYNDY ADAMS
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/29/1999
Decision Date 11/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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