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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K081335
Device Name TENACORE OXYGEN BLENDER, MODEL TB-2000
Applicant
TENACORE HOLDINGS, INC.
647 EAST YOUNG ST.
SANTA ANA,  CA  92705
Applicant Contact Brand Caso
Correspondent
TENACORE HOLDINGS, INC.
647 EAST YOUNG ST.
SANTA ANA,  CA  92705
Correspondent Contact Brand Caso
Regulation Number868.5330
Classification Product Code
BZR  
Date Received05/12/2008
Decision Date 11/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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