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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Exerciser, Finger, Powered
510(k) Number K880686
Device Name TORONTO/MOBILIMB HAND C.P.M.
Applicant
Toronto Medical Corp.
800 Livermore St.
Suite 117
Yellow Springs,  OH  45387
Applicant Contact DOUGLAS DAVIDSON
Correspondent
Toronto Medical Corp.
800 Livermore St.
Suite 117
Yellow Springs,  OH  45387
Correspondent Contact DOUGLAS DAVIDSON
Regulation Number890.5410
Classification Product Code
JFA  
Date Received02/19/1988
Decision Date 02/26/1988
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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