Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080442
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K080442
Device Name
Mesh, Surgical, Polymeric
Applicant
SERICA TECHNOLOGIES, INC.
200 BOSTON AVENUE
SUITE 3700
MEDFORD, MA 02155 US
Other 510(k) Applications for this Company
Contact
CONNIE H GARRISON
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/19/2008
Decision Date
11/13/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact