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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K920178
Device Name CARDIOTOMY RESERVOIR W/20 MICRON FILITER
Applicant
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Applicant Contact RUSSELL JONES
Correspondent
Lifestream Int'L, Inc.
2828 N.Crescent River Dr.
The Woodlands,  TX  77381
Correspondent Contact RUSSELL JONES
Regulation Number870.4400
Classification Product Code
DTN  
Date Received01/14/1992
Decision Date 05/13/1993
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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