510(k) K090909

C-QUR V -PATCH MESH by Atrium Medical Corp. — Product Code FTL

K090909 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "C-QUR V -PATCH MESH". The FDA issued a decision of Substantially Equivalent on June 4, 2009. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2009
Date Received
April 1, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type