Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K111137
Device Classification Name
Vessel Guard Or Cover
More FDA Info for this Device
510(K) Number
K111137
Device Name
Vessel Guard Or Cover
Applicant
MIMEDX GROUP INC
811 LIVINGSTON COURT SE
MARIETTA, GA 30067 US
Other 510(k) Applications for this Company
Contact
SALLY THORSEN
Other 510(k) Applications for this Contact
Regulation Number
870.3470
More FDA Info for this Regulation Number
Classification Product Code
OMR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/2011
Decision Date
05/20/2011
Decision
SESU - SE - WITH LIMITATIONS
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