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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K132857
Device Name RESPIRATORY GAS HUMIDIFIER
Applicant
PACIFIC MEDICO CO., LTD.
2-6-4 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Applicant Contact YOSHIO TOYAMA
Correspondent
PACIFIC MEDICO CO., LTD.
2-6-4 HONGO
BUNKYO-KU, TOKYO,  JP 113-0033
Correspondent Contact YOSHIO TOYAMA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/12/2013
Decision Date 05/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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