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510(k) K912045

TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST by Lifestream Int'L, Inc. — Product Code DXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
May 8, 1991
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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