The following data is part of a premarket notification filed by Rudolf Medical Gmbh + Co. Kg with the FDA for Laparoscopic And Electrosurgical Instruments And Accessories, Laparoscopy Rudolf System.
| Device ID | K073498 |
| 510k Number | K073498 |
| Device Name: | LAPAROSCOPIC AND ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, LAPAROSCOPY RUDOLF SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RUDOLF MEDICAL GMBH + CO. KG GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean RUDOLF MEDICAL GMBH + CO. KG GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-09-19 |
| Summary: | summary |