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510(k) K150408

V-STEADY, V-FAST by G21, S.R.L. — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2015
Date Received
February 18, 2015
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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