The following data is part of a premarket notification filed by Bowa-electronics Gmbh & Co. Kg with the FDA for Bowa Neutral Electrodes.
| Device ID | K173877 |
| 510k Number | K173877 |
| Device Name: | BOWA Neutral Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOWA-electronics GmbH & Co. KG Heinrich-Hertz-Strasse. 4-10 Gomaringen, DE 72810 |
| Contact | Wolf-ruediger Fritz |
| Correspondent | Roxana Cernescu EMERGO Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761085892 | K173877 | 000 |