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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K911151
Device Name POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM
Applicant
Tarsys Engineering, Inc.
101 Bartley Dr.
Toronto, Ontario, Canada
M4a 1c9,  CA
Applicant Contact NELSON PANG
Correspondent
Tarsys Engineering, Inc.
101 Bartley Dr.
Toronto, Ontario, Canada
M4a 1c9,  CA
Correspondent Contact NELSON PANG
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/15/1991
Decision Date 05/29/1991
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
Recalls CDRH Recalls
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