The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for Meniscotome 4mm & 5mm.
| Device ID | K841982 |
| 510k Number | K841982 |
| Device Name: | MENISCOTOME 4MM & 5MM |
| 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 |