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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 K905671
Device Name BRODA WHEELCHAIR
Applicant
Broda Ent., Inc.
72 Victoria St.
S., Kitchener
Ontario, Canada,  CA N2G 2A9
Applicant Contact JOHN ALLDREDGE
Correspondent
Broda Ent., Inc.
72 Victoria St.
S., Kitchener
Ontario, Canada,  CA N2G 2A9
Correspondent Contact JOHN ALLDREDGE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/18/1990
Decision Date 12/31/1990
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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