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FDA 510(k), K090288, ORTHADAPT PR
FDA 510(k), K090288, ORTHADAPT PR
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510(K) Number: K090288
Device Name: ORTHADAPT PR
Manufacturer: PEGASUS BIOLOGICS, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 02/05/2009
Decision Date: 05/05/2009
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ORTHADAPT PR
Manufacturer: PEGASUS BIOLOGICS, INC.
Device Classification Name: mesh, surgical, polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 02/05/2009
Decision Date: 05/05/2009
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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