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FDA 510(k) Application Details - K231092
Device Classification Name
Massager, Vacuum, Light Induced Heating
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510(K) Number
K231092
Device Name
Massager, Vacuum, Light Induced Heating
Applicant
B&M S.R.L. Marketing Nel Benessere
Via Leonardo Bruni, 25
Milano 20158 IT
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Contact
Brando Baldan
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Regulation Number
878.4810
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Classification Product Code
NUV
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More FDA Info for this Product Code
Date Received
04/18/2023
Decision Date
09/22/2023
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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