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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K082274
Device Name HAIDA MODEL HD11 MANUAL WHEELCHAIR
Applicant
Jiangyin East China Medical Technology Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Lane 25
Banqiao,  TW 220
Applicant Contact JUNNATA CHANG
Correspondent
Jiangyin East China Medical Technology Co., Ltd.
14f-2, # 1, Zhuangjing Rd.
Lane 25
Banqiao,  TW 220
Correspondent Contact JUNNATA CHANG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/11/2008
Decision Date 08/19/2008
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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