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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chair, With Casters
510(k) Number K880986
Device Name MECHANICAL WALKER
Applicant
Canhart Industries, Inc.
2020 Ellesmere Rd.
Scarborough, Ontario
Canada,  CA
Applicant Contact ADELE E WARD
Correspondent
Canhart Industries, Inc.
2020 Ellesmere Rd.
Scarborough, Ontario
Canada,  CA
Correspondent Contact ADELE E WARD
Regulation Number890.3100
Classification Product Code
INM  
Date Received03/08/1988
Decision Date 03/14/1988
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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