The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Fasiculated Nail.
| Device ID | K861365 |
| 510k Number | K861365 |
| Device Name: | FASICULATED NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jim Klosterman |
| Correspondent | Jim Klosterman LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1986-05-06 |