Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-