FDA 510(k) Application Details - K132558

Device Classification Name

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510(K) Number K132558
Device Name SYNC-RX SYSTEM
Applicant VOLCANO CORPORATION
1 FORTUNE DRIVE
BILLERICA, MA 01821 US
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Contact ELAINE ALAN
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Regulation Number

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Classification Product Code OWB
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Date Received 08/15/2013
Decision Date 12/12/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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