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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 K051583
Device Name TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
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 Received06/15/2005
Decision Date 11/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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