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FDA 510(k), K853126, BIO PACK MODEL 200
FDA 510(k), K853126, BIO PACK MODEL 200
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510(K) Number: K853126
Device Name: BIO PACK MODEL 200
Manufacturer: BIO MEDICUS, INC.
Device Classification Name: control, pump speed, cardiopulmonary bypass
Regulation Number: 870.4380
Classification Product Code: DWA
Date Received: 07/25/1985
Decision Date: 10/11/1985
Regulation Medical Specialty: Cardiovascular
Device Name: BIO PACK MODEL 200
Manufacturer: BIO MEDICUS, INC.
Device Classification Name: control, pump speed, cardiopulmonary bypass
Regulation Number: 870.4380
Classification Product Code: DWA
Date Received: 07/25/1985
Decision Date: 10/11/1985
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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