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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: 08/22/1988
Date Received: 04/14/1989
Decision Date: 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: 08/22/1988
Date Received: 04/14/1989
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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