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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dynamometer, Nonpowered
510(k) Number K970870
Device Name DIGIT-GRIP WITH LCD (DGR002)
Applicant
NK BIOTECHNICAL CORP.
10850 OLD COUNTY RD. 15
MINNEAPOLIS,  MN  55441
Applicant Contact KAREN GOTFREDSON
Correspondent
NK BIOTECHNICAL CORP.
10850 OLD COUNTY RD. 15
MINNEAPOLIS,  MN  55441
Correspondent Contact KAREN GOTFREDSON
Regulation Number888.1250
Classification Product Code
HRW  
Subsequent Product Code
KQX  
Date Received03/10/1997
Decision Date 05/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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