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FDA 510(k), K013527, MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
FDA 510(k), K013527, MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
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$49.00 USD
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510(K) Number: K013527
Device Name: MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
Manufacturer: BONNIE J SMITH
Device Classification Name: Reamer
Regulation Number: HTO
Classification Product Code: KXA
Date Received: 10/23/2001
Decision Date: 12/21/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
Manufacturer: BONNIE J SMITH
Device Classification Name: Reamer
Regulation Number: HTO
Classification Product Code: KXA
Date Received: 10/23/2001
Decision Date: 12/21/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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