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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 K041993
Device Name 2 CM PERIPHERAL CUTTING BALOON
Applicant
BOSTON SCIENTIFIC IVT
3574 RUFFIN RD.
SAN DIEGO,  CA  92123 -3597
Applicant Contact RENUKA KRISHNAN
Correspondent
BOSTON SCIENTIFIC IVT
3574 RUFFIN RD.
SAN DIEGO,  CA  92123 -3597
Correspondent Contact RENUKA KRISHNAN
Regulation Number870.1250
Classification Product Code
PNO  
Date Received07/23/2004
Decision Date 08/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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