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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 K071608
Device Name A&J POCA01 OXYGEN CONCENTRATOR
Applicant
Zhongshan A&J Medical Equipment Co., Ltd.
3 Shenghui S. Rd.
Nantou Town, Zhongshan City
Guangdong,  CN
Applicant Contact POLO CHEN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MICHELLE S LEE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/12/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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