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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 K100772
Device Name MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
Applicant
Resmed, Ltd.
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Applicant Contact DAVID D'CRUZ
Correspondent
Resmed, Ltd.
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/18/2010
Decision Date 06/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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