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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 K091541
Device Name MESA OXYGEN CONCENTRATOR, MODEL 2-6000 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 Received05/26/2009
Decision Date 12/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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