The following data is part of a premarket notification filed by Highland / Marietta, Inc. with the FDA for Endoscopic Monopolareectrode, Model Eme- 1000 To 1999.
| Device ID | K003403 |
| 510k Number | K003403 |
| Device Name: | ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 |
| Classification | Electrode, Electrosurgical |
| Applicant | HIGHLAND / MARIETTA, INC. 6155 HEISLEY RD. Mentor, OH 44060 |
| Contact | John Niksa |
| Correspondent | John Niksa HIGHLAND / MARIETTA, INC. 6155 HEISLEY RD. Mentor, OH 44060 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-05-07 |