FDA 510(k) Application Details - K191881

Device Classification Name Booth, Sun Tan

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510(K) Number K191881
Device Name Booth, Sun Tan
Applicant KBL GmbH
Ringstrasse 24-26
Dernbach 56307 DE
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Contact Ralf de Andreis
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Regulation Number 878.4635

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Classification Product Code LEJ
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Date Received 07/15/2019
Decision Date 10/28/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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