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FDA 510(k), K043248, TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
FDA 510(k), K043248, TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
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510(K) Number: K043248
Device Name: TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
Manufacturer: SALLY FOUST
Device Classification Name: Washer, Bolt Nut
Regulation Number: HTN
Classification Product Code: KXA
Date Received: 11/23/2004
Decision Date: 02/16/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
Manufacturer: SALLY FOUST
Device Classification Name: Washer, Bolt Nut
Regulation Number: HTN
Classification Product Code: KXA
Date Received: 11/23/2004
Decision Date: 02/16/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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