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FDA 510(k) Application Details - K041993
Device Classification Name
More FDA Info for this Device
510(K) Number
K041993
Device Name
2 CM PERIPHERAL CUTTING BALOON
Applicant
BOSTON SCIENTIFIC IVT
3574 RUFFIN RD.
SAN DIEGO, CA 92123-3597 US
Other 510(k) Applications for this Company
Contact
RENUKA KRISHNAN
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/23/2004
Decision Date
08/16/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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