The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Electrosugrical Resection And Vaporization Electrode Series.
Device ID | K120418 |
510k Number | K120418 |
Device Name: | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
Classification | Electrode, Electrosurgical, Active, Urological |
Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Contact | Sheri Musgnung |
Correspondent | Sheri Musgnung OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
Product Code | FAS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-10 |
Decision Date | 2012-06-20 |
Summary: | summary |