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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 K900938
Device Name MANUAL WHEELCHAIR
Applicant
Advanced Mobility Systems Corp.
621 Justus Dr.
Kingston, Ontario,  CA K7M 4H5
Applicant Contact HUGH BARCLAY
Correspondent
Advanced Mobility Systems Corp.
621 Justus Dr.
Kingston, Ontario,  CA K7M 4H5
Correspondent Contact HUGH BARCLAY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/28/1990
Decision Date 04/19/1990
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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