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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
510(k) Number K920783
Device Name OXYGEN FLOW CONTROLLER
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 Number868.2300
Classification Product Code
CCN  
Date Received02/20/1992
Decision Date 09/18/1992
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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