Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121311
Device Classification Name
Media,Coupling,Ultrasound
More FDA Info for this Device
510(K) Number
K121311
Device Name
Media,Coupling,Ultrasound
Applicant
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH
2670 LEAVENWORTH STREET
SAN FRANCISCO, CA 94133 US
Other 510(k) Applications for this Company
Contact
CHRISTINA BERNSTEIN
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
MUI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2012
Decision Date
08/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact