FDA 510(k) Application Details - K203665

Device Classification Name	More FDA Info for this Device
510(K) Number	K203665
Device Name	STOP U Model UXV Device
Applicant	Pollogen Ltd. 6 kaufman St. Tel Aviv 6801298 IL Other 510(k) Applications for this Company
Contact	Ayala Kamil Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2020
Decision Date	02/25/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review