FDA 510(k) K180121, Rafugen DBM, by Cellumed Co., Ltd.

FDA 510(k) K180121, Rafugen DBM, by Cellumed Co., Ltd.

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Device Classification Name: Filler, Bone Void, Calcium Compound
510(k) Number: K180121
Device Name: Rafugen DBM
Applicant: Cellumed Co., Ltd.
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 01/16/2018
Decision Date: 04/11/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic

Total number of pages: 1,923
Fully redacted pages: 1,627
Content pages: 296

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