FDA 510(k), K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI)
FDA 510(k), K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI)
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$149.00 USD
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$149.00 USD
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510(K) Number: K140300
Device Name: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
Manufacturer: ROTATION MEDICAL, INC.
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: 878.3300
Classification Product Code: OWY
Date Received: 02/06/2014
Decision Date: 03/26/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
Manufacturer: ROTATION MEDICAL, INC.
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: 878.3300
Classification Product Code: OWY
Date Received: 02/06/2014
Decision Date: 03/26/2014
Regulation Medical Specialty: General & Plastic Surgery