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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 K830844
Device Name PORTABLE OXYGEN SYSTEM
Applicant
PURITAN BENNETT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PURITAN BENNETT CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2700
Classification Product Code
CAN  
Date Received03/17/1983
Decision Date 05/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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