510(k) K896946

COATED NOVAFIL, POLYBUTESTER, MESH by American Cyanamid Co. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
December 13, 1989
Clearance Type
Traditional
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