The following data is part of a premarket notification filed by Erbe Electromedizin Gmbh with the FDA for Erbotom Acc 450.
| Device ID | K896055 |
| 510k Number | K896055 |
| Device Name: | ERBOTOM ACC 450 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE ELECTROMEDIZIN GMBH 9025 EAST KENYON Denver, CO 80237 |
| Contact | Robert Richards |
| Correspondent | Robert Richards ERBE ELECTROMEDIZIN GMBH 9025 EAST KENYON Denver, CO 80237 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1990-02-13 |