FDA 510(k) Application Details - K211272

Device Classification Name Massager, Vacuum, Light Induced Heating

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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
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Regulation Number 878.4810

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Classification Product Code NUV
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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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