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 |