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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
Applicant Contact GEORGE MESSING
Correspondent
Spiracle Technology
16912 Von Karman Ave.
Irvine,  CA  92606
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
Predetermined Change
Control Plan Authorized		 No
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