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FDA 510(k), K153502, ClariVein IC
FDA 510(k), K153502, ClariVein IC
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510(K) Number: K153502
Device Name: ClariVein IC
Manufacturer: LORRAINE M. HANLEY
Device Classification Name: Catheter, Continuous Flush
Regulation Number: KRA
Classification Product Code: KXA
Date Received: 12/07/2015
Decision Date: 01/06/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ClariVein IC
Manufacturer: LORRAINE M. HANLEY
Device Classification Name: Catheter, Continuous Flush
Regulation Number: KRA
Classification Product Code: KXA
Date Received: 12/07/2015
Decision Date: 01/06/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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