The following data is part of a premarket notification filed by Pajunk Gmbh with the FDA for Sono Tap, Tuohy Sono.
Device ID | K113207 |
510k Number | K113207 |
Device Name: | SONO TAP, TUOHY SONO |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
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 | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-31 |
Decision Date | 2012-02-29 |
Summary: | summary |