The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Vio Esu, Model Vio 300 D.
| Device ID | K060484 |
| 510k Number | K060484 |
| Device Name: | ERBE VIO ESU, MODEL VIO 300 D |
| 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 | 2006-02-24 |
| Decision Date | 2006-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147001626 | K060484 | 000 |
| 04050147001596 | K060484 | 000 |