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FDA 510(k) Application Details - K990713
Device Classification Name
Stylet, Catheter
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510(K) Number
K990713
Device Name
Stylet, Catheter
Applicant
SPECTRANETICS CORP.
96 TALAMINE CT.
COLORADO SPRINGS, CO 80907-5159 US
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Contact
MICHAEL J QUINN
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Regulation Number
870.1380
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Classification Product Code
DRB
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More FDA Info for this Product Code
Date Received
03/04/1999
Decision Date
10/22/1999
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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