The following data is part of a premarket notification filed by Celon Ag Medical Instruments with the FDA for Celon Ent System.
| Device ID | K032838 |
| 510k Number | K032838 |
| Device Name: | CELON ENT SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CELON AG MEDICAL INSTRUMENTS 8 RHEINSTRASSE Teltow, DE 14513 |
| Contact | Andre Roggan |
| Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2003-09-26 |
| Summary: | summary |