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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K850332
Device Name KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number890.5380
Classification Product Code
BXB  
Date Received01/28/1985
Decision Date 05/01/1985
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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