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FDA 510(k) Application Details - K082079
Device Classification Name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
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510(K) Number
K082079
Device Name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Applicant
REGEN BIOLOGICS, INC.
411 HACKENSACK AVENUE
HACKENSACK, NJ 07601 US
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Contact
JOHN DICHIARA
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Regulation Number
878.3300
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Classification Product Code
OLC
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Date Received
07/23/2008
Decision Date
12/18/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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