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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K910194
Device Name COMPANION 318 NASAL CPAP DIAGNOSTICS 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 Number868.5905
Classification Product Code
BZD  
Date Received01/16/1991
Decision Date 05/13/1991
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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