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510(k) K181282

G3A 40 Bone Cement by G21, S.R.L. — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2019
Date Received
May 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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