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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
510(k) Number K912428
Device Name PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
Applicant
Puritan Bennett Corp.
6088 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact STEPHAN NORSTED
Correspondent
Puritan Bennett Corp.
6088 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact STEPHAN NORSTED
Regulation Number868.1170
Classification Product Code
CBZ  
Date Received05/31/1991
Decision Date 08/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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