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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K902506
Device Name 7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
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 Number868.5895
Classification Product Code
CBK  
Date Received06/06/1990
Decision Date 01/08/1991
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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