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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K905530
Device Name PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
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 Number868.5935
Classification Product Code
BYT  
Date Received12/10/1990
Decision Date 03/01/1991
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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