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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K071761
Device Name LLOYD LINDEN, MODEL E04
Applicant
Lloyd Linden, Inc.
Zhuangjing Rd.
Banqiao, Taipei County,  TW 220
Applicant Contact JUNNATA CHANG
Correspondent
Lloyd Linden, Inc.
Zhuangjing Rd.
Banqiao, Taipei County,  TW 220
Correspondent Contact JUNNATA CHANG
Regulation Number890.3900
Classification Product Code
IPL  
Date Received06/29/2007
Decision Date 08/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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