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FDA 510(k), K061880, ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
FDA 510(k), K061880, ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
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510(K) Number: K061880
Device Name: ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
Manufacturer: ELAINE SCHUTTE
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: KXA
Date Received: 07/03/2006
Decision Date: 08/15/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
Manufacturer: ELAINE SCHUTTE
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: KXA
Date Received: 07/03/2006
Decision Date: 08/15/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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