Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K083523
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K083523
Device Name
Injector And Syringe, Angiographic
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
Other 510(k) Applications for this Company
Contact
SUSAN D SCOTT
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
DXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2008
Decision Date
02/04/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact