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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K971260
Device Name SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
Applicant
RESMED CORP.
5744 PACIFIC CENTER BLVD.,
SUITE 311
SAN DIEGO,  CA  92121
Applicant Contact MICHAEL HALLETT
Correspondent
RESMED CORP.
5744 PACIFIC CENTER BLVD.,
SUITE 311
SAN DIEGO,  CA  92121
Correspondent Contact MICHAEL HALLETT
Regulation Number868.5450
Classification Product Code
BTT  
Date Received04/04/1997
Decision Date 09/04/1997
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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