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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 K982530
Device Name SULLIVAN MIRAGE FULL FACE MASK
Applicant
RESMED LTD.
10121 CARROLL CANYON RD.
SAN DIEGO,  CA  92131
Applicant Contact SCOTT DUDEVOIR
Correspondent
RESMED LTD.
10121 CARROLL CANYON RD.
SAN DIEGO,  CA  92131
Correspondent Contact SCOTT DUDEVOIR
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/20/1998
Decision Date 10/16/1998
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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