The following data is part of a premarket notification filed by Cloverline International Pharma Services Gmbh with the FDA for Thixo-gel Ultrasound Spray.
| Device ID | K121311 |
| 510k Number | K121311 |
| Device Name: | THIXO-GEL ULTRASOUND SPRAY |
| Classification | Media, Coupling, Ultrasound |
| Applicant | CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH 2670 LEAVENWORTH STREET San Francisco, CA 94133 |
| Contact | Christina Bernstein |
| Correspondent | Christina Bernstein CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH 2670 LEAVENWORTH STREET San Francisco, CA 94133 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-08-30 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THIXO-GEL ULTRASOUND SPRAY 85007537 4268609 Dead/Cancelled |
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH 2010-04-06 |