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FDA 510(k) Application Details - K200734
Device Classification Name
More FDA Info for this Device
510(K) Number
K200734
Device Name
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Applicant
Sirius Medical Systems B.V.
High Tech Campus 41
Eindhoven 5656AE NL
Other 510(k) Applications for this Company
Contact
Bram Schermers
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2020
Decision Date
02/24/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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