FDA 510(k) Application Details - K220322

Device Classification Name	More FDA Info for this Device
510(K) Number	K220322
Device Name	Pollogen STOP U Model UXV Device
Applicant	Pollogen Ltd. 6 Kaufman St. Tel Aviv 6801298 IL Other 510(k) Applications for this Company
Contact	Elissa Burg 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	02/03/2022
Decision Date	05/04/2023
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