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FDA 510(k) Application Details - K221043
Device Classification Name
More FDA Info for this Device
510(K) Number
K221043
Device Name
Doctor Tecar Plus, Doctor Tecar Smart
Applicant
Mectronic Medicale S.r.l.
Via Orio al Serio 15
Grassobbio 24050 IT
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Contact
Gloria Aloisini
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/2022
Decision Date
02/17/2023
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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