The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for Rosette Knife 4mm.
| Device ID | K841975 |
| 510k Number | K841975 |
| Device Name: | ROSETTE KNIFE 4MM |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | STAINLESS MFG., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-14 |
| Decision Date | 1984-06-19 |