The following data is part of a premarket notification filed by Grass Instrument Co. with the FDA for Grass Model Nl Facial Nerve Locator & Monitor.
| Device ID | K844216 |
| 510k Number | K844216 |
| Device Name: | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | GRASS INSTRUMENT CO. 101 OLD COLONY AVENUE, P.O.BOX 516 Quincy, MA 02169 |
| Contact | Francis X Ridge |
| Correspondent | Francis X Ridge GRASS INSTRUMENT CO. 101 OLD COLONY AVENUE, P.O.BOX 516 Quincy, MA 02169 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-31 |
| Decision Date | 1985-01-18 |