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FDA 510(k), K883609, ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
FDA 510(k), K883609, ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
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510(K) Number: K883609
Device Name: ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
Manufacturer: LEONARD M BAUM
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: KXA
Date Received: 08/22/1988
Decision Date: 04/14/1989
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
Manufacturer: LEONARD M BAUM
Device Classification Name: Pump, Infusion
Regulation Number: FRN
Classification Product Code: KXA
Date Received: 08/22/1988
Decision Date: 04/14/1989
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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