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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 K010191
Device Name Y2000 POCKET RESCUE
Applicant
Cheen Houng Ent. Co. , Ltd.
23 San Dreen St., Alley 11,
Lane 65
Taipei (Shulin),  TW 23805
Applicant Contact JAY WANG
Correspondent
Cheen Houng Ent. Co. , Ltd.
23 San Dreen St., Alley 11,
Lane 65
Taipei (Shulin),  TW 23805
Correspondent Contact JAY WANG
Regulation Number868.5870
Classification Product Code
CBP  
Date Received01/22/2001
Decision Date 03/14/2001
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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