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FDA 510(k), K220635, Heater-Cooler System 3T
FDA 510(k), K220635, Heater-Cooler System 3T
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
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per
510(K) Number: K220635
Device Name: Heater-Cooler System 3T
Manufacturer: Julia E. Leslie
Device Classification Name: Controller, Temperature, Cardiopulmonary Bypass
Regulation Number: DWC
Classification Product Code: KXA
Date Received: 03/04/2022
Decision Date: 11/16/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Heater-Cooler System 3T
Manufacturer: Julia E. Leslie
Device Classification Name: Controller, Temperature, Cardiopulmonary Bypass
Regulation Number: DWC
Classification Product Code: KXA
Date Received: 03/04/2022
Decision Date: 11/16/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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