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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 K221070
Device Name DP4 Microneedling device
Applicant
Equipmed USA LLC
Suite 1100, 4695 Macarthur Court
Newport Beach,  CA  92660
Applicant Contact Shaun Kerrigan
Correspondent
Equipmed USA LLC
Suite 1100, 4695 Macarthur Court
Newport Beach,  CA  92660
Correspondent Contact Shaun Kerrigan
Regulation Number878.4430
Classification Product Code
QAI  
Date Received04/12/2022
Decision Date 12/20/2022
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
Predetermined Change
Control Plan Authorized		 No
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