The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Esu Model Vio 100 C With Accessories.
| Device ID | K101108 |
| 510k Number | K101108 |
| Device Name: | ERBE ESU MODEL VIO 100 C WITH ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147010116 | K101108 | 000 |
| 04050147010086 | K101108 | 000 |
| 04050147009905 | K101108 | 000 |