The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Catheter Clamping Adapter Luer 80369-7, Catheter Clamping Adapter Nrfit 80369-7.
| Device ID | K172777 |
| 510k Number | K172777 |
| Device Name: | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Contact | Christian G. H. Quass |
| Correspondent | Christian G. H. Quass PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen, DE 78187 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14048223033088 | K172777 | 000 |
| 14048223029982 | K172777 | 000 |
| 14048223016197 | K172777 | 000 |
| 14048223016098 | K172777 | 000 |
| 14048223016081 | K172777 | 000 |
| 04048223033081 | K172777 | 000 |
| 04048223029985 | K172777 | 000 |
| 04048223016190 | K172777 | 000 |
| 04048223016091 | K172777 | 000 |