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510(k) K900797

STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR by Shiley, Inc. — Product Code DXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1990
Date Received
February 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4310
Review Panel
CV
Submission Type

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  • K900548 — SHILEY PHONATION VALVE (April 23, 1990)

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