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510(k) K171629

ABCcolla Bone Graft by Acro Biomedical Co., Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2018
Date Received
June 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Acro Biomedical Co., Ltd.

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  • K212156 — ABCcolla Bone Matrix (October 8, 2021)
  • K162348 — ABCcolla Collagen Matrix (May 10, 2017)

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