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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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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