The following data is part of a premarket notification filed by Nk Biotechnical Corp. with the FDA for Digit-grip With Lcd (dgr002).
| Device ID | K970870 |
| 510k Number | K970870 |
| Device Name: | DIGIT-GRIP WITH LCD (DGR002) |
| Classification | Dynamometer, Nonpowered |
| Applicant | NK BIOTECHNICAL CORP. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Contact | Karen Gotfredson |
| Correspondent | Karen Gotfredson NK BIOTECHNICAL CORP. 10850 OLD COUNTY RD. 15 Minneapolis, MN 55441 |
| Product Code | HRW |
| CFR Regulation Number | 888.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-05-02 |