The following data is part of a premarket notification filed by Celon Ag Medical Instruments with the FDA for Olympus Esg-100, Model Wb991046; Olympus Afu-100, Model Wb950167.
| Device ID | K073207 |
| 510k Number | K073207 |
| Device Name: | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CELON AG MEDICAL INSTRUMENTS 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler CELON AG MEDICAL INSTRUMENTS 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-05-08 |
| Summary: | summary |