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510(k) K860672

ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL by American Bentley — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1986
Date Received
February 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

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  • K862549 — ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (July 15, 1986)

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