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FDA 510(k) Application Details - K201546
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K201546
Device Name
Bone Grafting Material, Synthetic
Applicant
RevisiOs BV
Professor Bronkhorstlaan 10, Building 48
3723 MB Bilthoven NL
Other 510(k) Applications for this Company
Contact
Hen Baron
Other 510(k) Applications for this Contact
Regulation Number
872.3930
More FDA Info for this Regulation Number
Classification Product Code
LYC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/09/2020
Decision Date
10/02/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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