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FDA 510(k), K864503, MODIFIED RLV-2100 B
FDA 510(k), K864503, MODIFIED RLV-2100 B
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510(K) Number: K864503
Device Name: MODIFIED RLV-2100 B
Manufacturer: AMERICAN OMNI MEDICAL, INC.
Device Classification Name: suction control, intracardiac, cardiopulmonary bypass
Regulation Number: 870.4430
Classification Product Code: DWD
Date Received: 11/14/1986
Decision Date: 01/06/1987
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFIED RLV-2100 B
Manufacturer: AMERICAN OMNI MEDICAL, INC.
Device Classification Name: suction control, intracardiac, cardiopulmonary bypass
Regulation Number: 870.4430
Classification Product Code: DWD
Date Received: 11/14/1986
Decision Date: 01/06/1987
Regulation Medical Specialty: Cardiovascular
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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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