The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Sono-series Cornerstone Technique.
| Device ID | K111374 | 
| 510k Number | K111374 | 
| Device Name: | SONO-SERIES CORNERSTONE TECHNIQUE | 
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) | 
| 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 | BSP | 
| CFR Regulation Number | 868.5150 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2011-05-16 | 
| Decision Date | 2011-08-29 |