FDA 510(k) Application Details - K202517

Device Classification Name	More FDA Info for this Device
510(K) Number	K202517
Device Name	Cytrellis Dermal Micro-Coring System
Applicant	Cytrellis Biosystems, Inc. 299C Washington St Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Karen H. Cronholm 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	09/01/2020
Decision Date	07/09/2021
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