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FDA 510(k), K073166, ENDOWAVE INFUSION SYSTEM
FDA 510(k), K073166, ENDOWAVE INFUSION SYSTEM
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510(K) Number: K073166
Device Name: ENDOWAVE INFUSION SYSTEM
Manufacturer: EKOS CORP.
Device Classification Name: catheter, continuous flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 11/09/2007
Decision Date: 04/22/2008
Regulation Medical Specialty: Cardiovascular
Device Name: ENDOWAVE INFUSION SYSTEM
Manufacturer: EKOS CORP.
Device Classification Name: catheter, continuous flush
Regulation Number: 870.1210
Classification Product Code: KRA
Date Received: 11/09/2007
Decision Date: 04/22/2008
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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