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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dynamometer, ac-powered
510(k) Number K981730
FOIA Releasable 510(k) K981730
Device Name DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
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 Number888.1240
Classification Product Code
LBB  
Date Received05/15/1998
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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