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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K914062
Device Name NK DEXTERITLY BOARD, MODEL BX001
Applicant
Nk Biotechnical Engineering Co.
P.O. Box 26335
Minneapolis,  MN  55426
Applicant Contact KAREN GOTFREDSON
Correspondent
Nk Biotechnical Engineering Co.
P.O. Box 26335
Minneapolis,  MN  55426
Correspondent Contact KAREN GOTFREDSON
Regulation Number888.1500
Classification Product Code
KQX  
Date Received09/10/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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