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FDA 510(k) Application Details - K181342
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K181342
Device Name
Filler, Bone Void, Calcium Compound
Applicant
AgNovos Healthcare USA, LLC
7301 Calhoun Place, Suite 100
Rockville, MD 20855 US
Other 510(k) Applications for this Company
Contact
Felipe Aguel
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
05/21/2018
Decision Date
07/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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