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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K953349
Device Name SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
Applicant
SPIRACLE TECHNOLOGY
16912 VON KARMAN AVE.
IRVINE,  CA  92606 -4923
Applicant Contact GEORGE MESSING
Correspondent
SPIRACLE TECHNOLOGY
16912 VON KARMAN AVE.
IRVINE,  CA  92606 -4923
Correspondent Contact GEORGE MESSING
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/17/1995
Decision Date 02/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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