The following data is part of a premarket notification filed by Trokamed Gmbh with the FDA for Trokamed Gmbh Electrosurgical Instruments & Accessories.
| Device ID | K060232 |
| 510k Number | K060232 |
| Device Name: | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TROKAMED GMBH KLEINE BREITE 17 Geisingen, DE 78187 |
| Contact | Karlheinz Trondle |
| Correspondent | Karlheinz Trondle TROKAMED GMBH KLEINE BREITE 17 Geisingen, DE 78187 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-30 |
| Decision Date | 2006-07-12 |
| Summary: | summary |