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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K051254
Device Name PERIPHERAL CUTTING BALLOON
Applicant
Boston Scientific Ivt
3574 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact RENUKA KRISHNAN
Correspondent
Boston Scientific Ivt
3574 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact RENUKA KRISHNAN
Regulation Number870.1250
Classification Product Code
PNO  
Date Received05/16/2005
Decision Date 06/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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