The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Erbe Apcapplicators.
| Device ID | K183445 |
| 510k Number | K183445 |
| Device Name: | Erbe APCapplicators |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Contact | Julia Weller |
| Correspondent | Julia Weller Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147018181 | K183445 | 000 |
| 04050147018228 | K183445 | 000 |
| 04050147018211 | K183445 | 000 |
| 04050147018204 | K183445 | 000 |
| 04050147018198 | K183445 | 000 |
| 04050147017795 | K183445 | 000 |
| 04050147017771 | K183445 | 000 |