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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 K882292
Device Name SULLIVAN NASAL CPAP SYSTEM
Applicant
BAXTER CENTRE FOR MEDICAL RESEARCH
P.O. BOX 185, NORTH RYDE, 2113
376-380 LANE COVE ROAD
NORTH RYDE, N.S.W. 2113,  AU
Applicant Contact CHRIS LYNCH
Correspondent
BAXTER CENTRE FOR MEDICAL RESEARCH
P.O. BOX 185, NORTH RYDE, 2113
376-380 LANE COVE ROAD
NORTH RYDE, N.S.W. 2113,  AU
Correspondent Contact CHRIS LYNCH
Regulation Number868.5965
Classification Product Code
BYE  
Date Received06/01/1988
Decision Date 06/21/1988
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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