The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunks Disposable Inserts For Handle Instruments And Hf Electrodes.
| Device ID | K062072 |
| 510k Number | K062072 |
| Device Name: | PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-09-22 |
| Summary: | summary |