The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbotom Icc 50.
| Device ID | K935815 |
| 510k Number | K935815 |
| Device Name: | ERBOTOM ICC 50 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 775 OXFORD HALL DR. Lawrenceville, GA 30244 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark ERBE USA, INC. 775 OXFORD HALL DR. Lawrenceville, GA 30244 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-03-31 |