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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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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