Home / 510(k) Clearances / K041889

510(k) K041889

TRI-OSTETIC by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2004
Date Received
July 12, 2004
Clearance Type
Special
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

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