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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 K050708
Device Name LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000
Applicant
Lerado Oversea Ltd. Twn Branch (Bvi)
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Lerado Oversea Ltd. Twn Branch (Bvi)
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/18/2005
Decision Date 04/26/2005
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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