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510(k) K092046

BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2010
Date Received
July 6, 2009
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

Other clearances by Berkeley Advanced Biomaterials, Inc.

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  • K113791 — B-GENIN, R-GENIN (March 15, 2012)
  • K091912 — B-GENIN AND R-GENIN (June 23, 2010)
  • K053213 — BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (July 6, 2006)
  • K051914 — GENEROS 80, GENEROS 60 (November 3, 2005)
  • K051695 — MARROW PLUS (M+) (July 19, 2005)
  • K050666 — GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, (April 11, 2005)
  • K042636 — BIOPLUS (December 14, 2004)
  • 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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