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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 K844799
Device Name ARTISAN FOLDING WHEELCHAIRS
Applicant
Artisan Wheel Chair Manufacturers
# 10, Aly. 13, Ln. 119 - 2
Chung-Shan Rd.
Shu Lin, Taipei Hsien,  TW
Applicant Contact JOHNSON WU
Correspondent
Artisan Wheel Chair Manufacturers
# 10, Aly. 13, Ln. 119 - 2
Chung-Shan Rd.
Shu Lin, Taipei Hsien,  TW
Correspondent Contact JOHNSON WU
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/11/1984
Decision Date 03/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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