FDA 510(k) Application Details - K233709

Device Classification Name

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510(K) Number K233709
Device Name Exceed Unlimited
Applicant Mt.Derm GmbH
Blohmstr. 37-61
Berlin 12307 DE
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Contact Andreas Pachten
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Regulation Number

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Classification Product Code QAI
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Date Received 11/20/2023
Decision Date 02/23/2024
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

FDA Source Information for K233709


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