The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Pajunk's Primocut Disposable Biopsy System.
| Device ID | K080674 |
| 510k Number | K080674 |
| Device Name: | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM |
| Classification | Device, Percutaneous, Biopsy |
| 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 | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048223131923 | K080674 | 000 |
| 04048223128947 | K080674 | 000 |
| 04048223128893 | K080674 | 000 |
| 04048223113851 | K080674 | 000 |
| 04048223015698 | K080674 | 000 |
| 04048223128954 | K080674 | 000 |