FDA 510(k) Application Details - K182407

Device Classification Name	More FDA Info for this Device
510(K) Number	K182407
Device Name	Exceed Microneedling device
Applicant	Mt. Derm GmbH Gustav-Krone-Str.3 Berlin 14167 DE Other 510(k) Applications for this Company
Contact	Andreas Pachten Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2018
Decision Date	07/19/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review