The following data is part of a premarket notification filed by Erbe Electromedizin Gmbh with the FDA for Erbotom Icc 300.
| Device ID | K953738 |
| 510k Number | K953738 |
| Device Name: | ERBOTOM ICC 300 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE ELECTROMEDIZIN GMBH 1070 THORNWOOD LAND Dacula, GA 30211 -3007 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark ERBE ELECTROMEDIZIN GMBH 1070 THORNWOOD LAND Dacula, GA 30211 -3007 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-10 |
| Decision Date | 1995-10-16 |