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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K063354
Device Name LINDE INTEGRATED VALVE (LIV)
Applicant
LINDE GAS THERAPEUTICS
P.O. BOX 470218
BROADVIEW HEIGHTS,  OH  44147
Applicant Contact JAMES J ROGERS
Correspondent
LINDE GAS THERAPEUTICS
P.O. BOX 470218
BROADVIEW HEIGHTS,  OH  44147
Correspondent Contact JAMES J ROGERS
Regulation Number868.2700
Classification Product Code
ECX  
Date Received11/06/2006
Decision Date 04/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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