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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K896152
Device Name PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact MARSHALL SMITH
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact MARSHALL SMITH
Regulation Number868.2700
Classification Product Code
CAN  
Date Received10/24/1989
Decision Date 01/09/1990
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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