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 |