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FDA 510(k) Application Details - K182074
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K182074
Device Name
Filler, Bone Void, Calcium Compound
Applicant
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436 US
Other 510(k) Applications for this Company
Contact
Gloria Zuclich
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2018
Decision Date
03/21/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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