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FDA 510(k) Application Details - K151904
Device Classification Name
More FDA Info for this Device
510(K) Number
K151904
Device Name
SyncVision System
Applicant
VOLCANO CORPORATION
1 FORTUNE DR.
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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More FDA Info for this Product Code
Date Received
07/13/2015
Decision Date
07/31/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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