The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Resection Electrodes.
Device ID | K161600 |
510k Number | K161600 |
Device Name: | Resection Electrodes |
Classification | Electrode, Electrosurgical |
Applicant | OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg, DE 22045 |
Contact | Katharina Campbell |
Correspondent | Dolan Mills GYRUS ACMI, INC. 136 TURNPIKE ROAD Southborough, MA 01772 |
Product Code | JOS |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-09 |
Decision Date | 2016-09-06 |
Summary: | summary |