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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 K900794
Device Name MOBILIMB H3 HAND CPM UNIT
Applicant
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Applicant Contact JEFF HARMON
Correspondent
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Correspondent Contact JEFF HARMON
Regulation Number890.5410
Classification Product Code
JFA  
Date Received02/20/1990
Decision Date 03/02/1990
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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