510(k) K840172

VENTRAL WALL DEFECT REDUCT SILO by American Heyer Schulte — Product Code FTL

K840172 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "VENTRAL WALL DEFECT REDUCT SILO". The FDA issued a decision of Substantially Equivalent on June 27, 1984. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. American Heyer Schulte has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1984
Date Received
January 17, 1984
Clearance Type
Traditional
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