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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered microneedle device
510(k) Number K182407
Device Name Exceed Microneedling device
Applicant
Mt. Derm GmbH
Gustav-Krone-Str.3
Berlin,  DE 14167
Applicant Contact Andreas Pachten
Correspondent
Ismart Marketing Svcs
129 Green Lanes, Wylde Green
Birmingham,  GB B735LT
Correspondent Contact Susan D'Arcy
Regulation Number878.4430
Classification Product Code
QAI  
Date Received09/04/2018
Decision Date 07/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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