The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set.
| Device ID | K053283 |
| 510k Number | K053283 |
| Device Name: | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET |
| Classification | Anesthesia Conduction Kit |
| 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 | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223131756 | K053283 | 000 |
| 04048223128787 | K053283 | 000 |
| 04048223128749 | K053283 | 000 |
| 04048223128725 | K053283 | 000 |
| 04048223128343 | K053283 | 000 |
| 04048223128244 | K053283 | 000 |