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FDA 510(k), K131146, ARTASSIST AND VENASSIST
FDA 510(k), K131146, ARTASSIST AND VENASSIST
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510(K) Number: K131146
Device Name: ARTASSIST AND VENASSIST
Manufacturer: ACI MEDICAL, LLC
Device Classification Name: sleeve, limb, compressible
Regulation Number: 870.5800
Classification Product Code: JOW
Date Received: 04/23/2013
Decision Date: 02/10/2014
Regulation Medical Specialty: Cardiovascular
Device Name: ARTASSIST AND VENASSIST
Manufacturer: ACI MEDICAL, LLC
Device Classification Name: sleeve, limb, compressible
Regulation Number: 870.5800
Classification Product Code: JOW
Date Received: 04/23/2013
Decision Date: 02/10/2014
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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