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FDA 510(k), K112525, D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
FDA 510(k), K112525, D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
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510(K) Number: K112525
Device Name: D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Manufacturer: BARRY SALL
Device Classification Name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation Number: DTM
Classification Product Code: 08/31/2011
Date Received: 09/29/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Manufacturer: BARRY SALL
Device Classification Name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation Number: DTM
Classification Product Code: 08/31/2011
Date Received: 09/29/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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