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 |