510(k) K121311

THIXO-GEL ULTRASOUND SPRAY by Cloverline International Pharma Services GmbH — Product Code MUI

K121311 is an FDA 510(k) premarket notification submitted by Cloverline International Pharma Services GmbH for the device "THIXO-GEL ULTRASOUND SPRAY". The FDA issued a decision of Substantially Equivalent on Aug 30, 2012. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 30, 2012
Date Received
May 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type