The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Adaptable Monopolar Electrodes With Ceramic Tip.
| Device ID | K053282 |
| 510k Number | K053282 |
| Device Name: | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH KARL-HALL-STRASSE 1 Geisingen, DE D-78187 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2005-12-13 |
| Summary: | summary |