The following data is part of a premarket notification filed by Highland / Marietta, Inc. with the FDA for Endoscopic Monopolar Forceps-scissors, Emf-2000 To 2999,endoscopics Monopolarfoeps-graspers, Emf-3000 To 3999, Endoscopo.
| Device ID | K003405 |
| 510k Number | K003405 |
| Device Name: | ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| 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 | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-05-07 |