The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunk Infiltralong Wound Infiltration Catheter Kit.
| Device ID | K080675 |
| 510k Number | K080675 |
| Device Name: | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT |
| Classification | Catheter, Conduction, Anesthetic |
| 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 | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223132432 | K080675 | 000 |
| 04048223129609 | K080675 | 000 |
| 04048223129623 | K080675 | 000 |
| 04048223129661 | K080675 | 000 |
| 04048223129760 | K080675 | 000 |
| 04048223132180 | K080675 | 000 |
| 04048223132203 | K080675 | 000 |
| 04048223132227 | K080675 | 000 |
| 04048223132265 | K080675 | 000 |
| 04048223132401 | K080675 | 000 |
| 04048223129579 | K080675 | 000 |