Home / 510(k) Clearances / K042636

510(k) K042636

BIOPLUS by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2004
Date Received
September 27, 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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  • K041889 — TRI-OSTETIC (August 19, 2004)
  • K040405 — CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY (March 5, 2004)

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