The following data is part of a premarket notification filed by Evermed, Inc. with the FDA for Steiger Tunneling Instrument 285.
| Device ID | K840529 |
| 510k Number | K840529 |
| Device Name: | STEIGER TUNNELING INSTRUMENT 285 |
| Classification | Trocar |
| Applicant | EVERMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-08 |
| Decision Date | 1984-03-12 |