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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K922178
Device Name COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
Applicant
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Applicant Contact MARSHALL SMITH
Correspondent
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Correspondent Contact MARSHALL SMITH
Regulation Number868.5965
Classification Product Code
BYE  
Date Received05/08/1992
Decision Date 05/29/1992
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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