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FDA 510(k), K123128, SERI SURGICAL SCAFFOLD
FDA 510(k), K123128, SERI SURGICAL SCAFFOLD
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510(K) Number: K123128
Device Name: SERI SURGICAL SCAFFOLD
Manufacturer: CONNIE GARRISON
Device Classification Name: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation Number: OXF
Classification Product Code: KXA
Date Received: 10/04/2012
Decision Date: 04/25/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SERI SURGICAL SCAFFOLD
Manufacturer: CONNIE GARRISON
Device Classification Name: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Regulation Number: OXF
Classification Product Code: KXA
Date Received: 10/04/2012
Decision Date: 04/25/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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