The following data is part of a premarket notification filed by Rln Systems, Inc. with the FDA for Hemostat/stimulator Probe.
| Device ID | K895676 |
| 510k Number | K895676 |
| Device Name: | HEMOSTAT/STIMULATOR PROBE |
| Classification | Stimulator, Nerve |
| Applicant | RLN SYSTEMS, INC. BOX 6757 2019 HONEYSUCKLE LN. Jefferson City, MO 65101 |
| Contact | Rea, M.d. |
| Correspondent | Rea, M.d. RLN SYSTEMS, INC. BOX 6757 2019 HONEYSUCKLE LN. Jefferson City, MO 65101 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-12-08 |