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FDA 510(k) Application Details - K191881
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K191881
Device Name
Booth, Sun Tan
Applicant
KBL GmbH
Ringstrasse 24-26
Dernbach 56307 DE
Other 510(k) Applications for this Company
Contact
Ralf de Andreis
Other 510(k) Applications for this Contact
Regulation Number
878.4635
More FDA Info for this Regulation Number
Classification Product Code
LEJ
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More FDA Info for this Product Code
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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