The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Chiba Sono.
| Device ID | K113209 |
| 510k Number | K113209 |
| Device Name: | CHIBA SONO |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2011-11-21 |
| Summary: | summary |