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FDA 510(k) Application Details - K092378
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K092378
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS, CO 80907-5159 US
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Contact
CHERYL HASTINGS
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Regulation Number
870.1310
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Classification Product Code
DRE
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More FDA Info for this Product Code
Date Received
08/05/2009
Decision Date
11/02/2009
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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