FDA 510(k) Application Details - K213295

Device Classification Name

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510(K) Number K213295
Device Name C.C. LIFE 21
Applicant 21 Equipment S.R.L.
Piazza Bodoni 3
Torino 10123 IT
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Contact Dolores Moretto
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Regulation Number

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Classification Product Code PBX
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Date Received 10/01/2021
Decision Date 11/17/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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