The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Model Vio 300 D With Accessories.
| Device ID | K083452 |
| 510k Number | K083452 |
| Device Name: | ERBE MODEL VIO 300 D WITH ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens ERBE USA, INC. 111 LAUREL RIDGE DRIVE Alpharetta, GA 30004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-21 |
| Decision Date | 2008-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147018419 | K083452 | 000 |
| 04050147000216 | K083452 | 000 |
| 04050147010079 | K083452 | 000 |
| 04050147014879 | K083452 | 000 |
| 04050147015388 | K083452 | 000 |
| 04050147015395 | K083452 | 000 |
| 04050147015401 | K083452 | 000 |
| 04050147017665 | K083452 | 000 |
| 04050147018297 | K083452 | 000 |
| 04050147018389 | K083452 | 000 |
| 04050147018396 | K083452 | 000 |
| 04050147018402 | K083452 | 000 |
| 04050147000209 | K083452 | 000 |