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FDA 510(k) Application Details - K242302
Device Classification Name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
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510(K) Number
K242302
Device Name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 US
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Contact
Devin Dragon
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Regulation Number
878.3300
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Classification Product Code
OLC
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More FDA Info for this Product Code
Date Received
08/05/2024
Decision Date
10/02/2024
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
FDA Source Information for K242302
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