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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 K212558
Device Name MicroPen EVO
Applicant
Eclipse Medcorp LLC
5916 Stone Creek Drive
the colony,  TX  75056
Applicant Contact julie summerville
Correspondent
Eclipse Medcorp LLC
5916 Stone Creek Drive
the colony,  TX  75056
Correspondent Contact julie summerville
Regulation Number878.4430
Classification Product Code
QAI  
Date Received08/13/2021
Decision Date 11/24/2021
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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