The following data is part of a premarket notification filed by Nk Biotechnical Engineering Co. with the FDA for Nk Medical Micrometer, Model Mc001.
| Device ID | K921266 |
| 510k Number | K921266 |
| Device Name: | NK MEDICAL MICROMETER, MODEL MC001 |
| Classification | Caliper |
| Applicant | NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Contact | Karen Gotgredson |
| Correspondent | Karen Gotgredson NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Product Code | KTZ |
| CFR Regulation Number | 888.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-16 |
| Decision Date | 1992-07-14 |