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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K895141
Device Name MODEL 590 OXYGEN CONCENTRATOR
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 Number868.5440
Classification Product Code
CAW  
Date Received08/16/1989
Decision Date 10/31/1989
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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