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FDA 510(k) Application Details - K202338
Device Classification Name
Bone Cement, Antibiotic
More FDA Info for this Device
510(K) Number
K202338
Device Name
Bone Cement, Antibiotic
Applicant
G21 Srl
Via Sandro Pertini, 8
San Possidonio 41039 IT
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Contact
Filippo Foroni
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
MBB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2020
Decision Date
02/17/2021
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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