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FDA 510(k), K110815, PARIETEX OPTIMIZED COMPOSTIE MESH
FDA 510(k), K110815, PARIETEX OPTIMIZED COMPOSTIE MESH
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510(K) Number: K110815
Device Name: PARIETEX OPTIMIZED COMPOSTIE MESH
Manufacturer: JAMES MCMAHON
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 03/24/2011
Decision Date: 04/19/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PARIETEX OPTIMIZED COMPOSTIE MESH
Manufacturer: JAMES MCMAHON
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 03/24/2011
Decision Date: 04/19/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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