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510(k) K081335

TENACORE OXYGEN BLENDER, MODEL TB-2000 by Tenacore Holdings, Inc. — Product Code BZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2008
Date Received
May 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

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  • K012041 — THE HAMMER MODEL H100 (March 28, 2002)

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