The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbotom Icc 200.
| Device ID | K933157 |
| 510k Number | K933157 |
| Device Name: | ERBOTOM ICC 200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 775 OXFORD HALL DR. Lawrenceville, GA 30244 |
| Contact | Michael Clark |
| Correspondent | Michael 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 | 1993-06-29 |
| Decision Date | 1994-02-23 |
| Summary: | summary |