The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Plexolong Sets.
| Device ID | K013041 |
| 510k Number | K013041 |
| Device Name: | PLEXOLONG SETS |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GMBH 5010 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
| Contact | Burk A Brandt |
| Correspondent | Burk A Brandt PAJUNK GMBH 5010 NW CRESCENT VALLEY DR. Corvallis, OR 97330 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2002-06-11 |
| Summary: | summary |