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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, non-life-supporting
510(k) Number K974417
Device Name SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
Applicant
RESMED CORP.
10121 CAROLL CANYON RD.
SAN DIEGO,  CA  92131
Applicant Contact SCOTT DUDEVOIR
Correspondent
RESMED CORP.
10121 CAROLL CANYON RD.
SAN DIEGO,  CA  92131
Correspondent Contact SCOTT DUDEVOIR
Regulation Number868.5895
Classification Product Code
MNS  
Date Received11/24/1997
Decision Date 06/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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