FDA 510(k), K051410, ACUMED RIB CONGRIENT BONE PLATE SYSTEM

FDA 510(k), K051410, ACUMED RIB CONGRIENT BONE PLATE SYSTEM

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510(K) Number: K051410
Device Name: ACUMED RIB CONGRIENT BONE PLATE SYSTEM
Manufacturer: ED BOEHMER
Device Classification Name: Plate, Fixation, Bone
Regulation Number: HRS
Classification Product Code: KXA
Date Received: 05/31/2005
Decision Date: 07/21/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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