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FDA 510(k) Application Details - K210867
Device Classification Name
More FDA Info for this Device
510(K) Number
K210867
Device Name
NuEra Tight RF, NuEra Tight RF Plus
Applicant
BIOS s.r.l.
Via Guido Rossa 10/12
Vimodrone 20090 IT
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Contact
Eliana Russo
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Regulation Number
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Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2021
Decision Date
04/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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