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510(k) K040405

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2004
Date Received
February 17, 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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  • K042636 — BIOPLUS (December 14, 2004)
  • K041889 — TRI-OSTETIC (August 19, 2004)

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