FDA 510(k) K070961, BIOMERIX SURGICAL MESH, MODEL: RCR-01, by Biomerix Corporation

510(K) Number: K070961
Device Name: BIOMERIX SURGICAL MESH, MODEL: RCR-01
Manufacturer: Biomerix Corporation
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 04/05/2007
Decision Date: 02/25/2008
Regulation Medical Specialty: General & Plastic Surgery