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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Pressure, Coronary, Cardiopulmonary Bypass
510(k) Number K912045
Device Name TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
Applicant
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Applicant Contact KRISTA OAKES
Correspondent
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Correspondent Contact KRISTA OAKES
Regulation Number870.4310
Classification Product Code
DXS  
Date Received05/08/1991
Decision Date 10/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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