510(k) K041140

ACELL UBM SURGICAL MESH ML AND MLPLUS by Acell, Inc. — Product Code FTM

K041140 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "ACELL UBM SURGICAL MESH ML AND MLPLUS". The FDA issued a decision of Substantially Equivalent on Jul 7, 2004. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Acell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 7, 2004
Date Received
Apr 30, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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