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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K981415
Device Name 0-20 CM H20 PEEP VALVE
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 Number868.5965
Classification Product Code
BYE  
Date Received04/20/1998
Decision Date 07/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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