FDA 510(k) Application Details - K203144

Device Classification Name	More FDA Info for this Device
510(K) Number	K203144
Device Name	MicroPen EVO
Applicant	Eclipse MedCorp, LLC 5916 Stone Creek Drive The Colony, TX 75056 US Other 510(k) Applications for this Company
Contact	Julie Summerville 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	10/21/2020
Decision Date	05/25/2021
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