The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunk's Generic Convenience Tray For Regional Anesthesia Of The Peripheral Plexus: Single Shot.
| Device ID | K082164 |
| 510k Number | K082164 |
| Device Name: | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT |
| Classification | Anesthesia Conduction Kit |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian G Quass |
| Correspondent | Christian G Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-07-31 |
| Decision Date | 2008-10-27 |
| Summary: | summary |