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FDA 510(k), K093123, BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
FDA 510(k), K093123, BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
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510(K) Number: K093123
Device Name: BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
Manufacturer: BIOMERIX CORPORATION
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 10/02/2009
Decision Date: 05/13/2010
Regulation Medical Specialty: General & Plastic Surgery
Device Name: BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
Manufacturer: BIOMERIX CORPORATION
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 10/02/2009
Decision Date: 05/13/2010
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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