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510(k) K911884

ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES by Advance Medical Designs, Inc. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
April 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type

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  • K911732 — ADVANCE DISPOSABLE CONTROL SYRINGE (September 16, 1991)

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