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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 K942246
FOIA Releasable 510(k) K942246
Device Name PURITAN-BENNETT NASAL CPAP MASK
Applicant
Puritan-Bennett
10800 Pflumm Rd.
Lenexa,  KS  66215
Applicant Contact MARSHALL C SMITH
Correspondent
Puritan-Bennett
10800 Pflumm Rd.
Lenexa,  KS  66215
Correspondent Contact MARSHALL C SMITH
Regulation Number868.5965
Classification Product Code
BYE  
Date Received05/09/1994
Decision Date 07/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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