The following data is part of a premarket notification filed by Conmedcorp with the FDA for Ultrapen Reusable Pencil, Model 130350 Through 130353, Reusable Accessory Electrode Kit (for Use With Ultrapen Pencil),.
| Device ID | K001161 |
| 510k Number | K001161 |
| Device Name: | ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMEDCORP 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Contact | Charles M (mike) Hart |
| Correspondent | Charles M (mike) Hart CONMEDCORP 14603 E. FREMONT AVE. Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-06-07 |