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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 K952292
Device Name PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM
Applicant
PURITAN BENNETT CORP.
9728 PFLUMM RD.
P.O.BOX 15915
LENEXA,  KS  66215 -5915
Applicant Contact C. MARSHALL SMITH
Correspondent
PURITAN BENNETT CORP.
9728 PFLUMM RD.
P.O.BOX 15915
LENEXA,  KS  66215 -5915
Correspondent Contact C. MARSHALL SMITH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/16/1995
Decision Date 11/13/1995
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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