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FDA 510(k) Application Details - K211272
Device Classification Name
Massager, Vacuum, Light Induced Heating
More FDA Info for this Device
510(K) Number
K211272
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
I-Tech Industries SRL
Via Casalino 5/H
Bergamo 24121 IT
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Contact
Gianfranco Tudico
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NUV
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More FDA Info for this Product Code
Date Received
04/27/2021
Decision Date
06/22/2021
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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