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FDA 510(k) Application Details - K060960
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K060960
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Boston Scientific Corporation
TWO SCIMED PLACE
MAPLE GROVE, MN 55311 US
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Contact
SARA L COON
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Regulation Number
870.1250
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Classification Product Code
LIT
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More FDA Info for this Product Code
Date Received
04/07/2006
Decision Date
04/12/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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