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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 K945177
Device Name 4-O2 JR. (CPR MOUTH BARRIER)
Applicant
EAGLE HEALTH SUPPLIES
231 E. EMERSON DR.
ORANGE,  CA  92665
Applicant Contact VINCENT CHAN
Correspondent
EAGLE HEALTH SUPPLIES
231 E. EMERSON DR.
ORANGE,  CA  92665
Correspondent Contact VINCENT CHAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/24/1994
Decision Date 11/01/1994
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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