The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Esg-400 Model Wb95051n, Footswitch Double Pedal Model Wb50402w, Footswitch Single Pedal Model Wb50403w, P-cord Model Maj.
| Device ID | K103032 |
| 510k Number | K103032 |
| Device Name: | ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-01-14 |
| Summary: | summary |