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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K100920
Device Name MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
Applicant
SEQUAL TECHNOLOGIES CO., LTD
6F-7, NO.136, SEC. 3
REN-AI RD
TAIPEI,  TW 10657
Applicant Contact CEARO HUANG
Correspondent
SEQUAL TECHNOLOGIES CO., LTD
6F-7, NO.136, SEC. 3
REN-AI RD
TAIPEI,  TW 10657
Correspondent Contact CEARO HUANG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/02/2010
Decision Date 11/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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