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FDA 510(k), K133265, QUADROX-IR ADULT AND SMALL ADULT
FDA 510(k), K133265, QUADROX-IR ADULT AND SMALL ADULT
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510(K) Number: K133265
Device Name: QUADROX-IR ADULT AND SMALL ADULT
Manufacturer: WHITNEY TORNING
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: KXA
Date Received: 10/23/2013
Decision Date: 11/12/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QUADROX-IR ADULT AND SMALL ADULT
Manufacturer: WHITNEY TORNING
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: KXA
Date Received: 10/23/2013
Decision Date: 11/12/2013
Decision: Substantially Equivalent (SESE)
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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