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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 K043382
Device Name TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
Applicant
Tiara Medical Systems, Inc.
14414 Detroit Ave., Suite 205
Lakewood,  OH  44107
Applicant Contact GEOFFREY SLEEPER
Correspondent
Tiara Medical Systems, Inc.
14414 Detroit Ave., Suite 205
Lakewood,  OH  44107
Correspondent Contact GEOFFREY SLEEPER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/09/2004
Decision Date 01/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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