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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
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