FDA 510(k) Application Details - K182774

Device Classification Name	More FDA Info for this Device
510(K) Number	K182774
Device Name	STOP U (Packed Black USA), STOP U (Packed White USA)
Applicant	Pollogen Ltd. 6 Kaufman St. Tel Aviv 6801298 IL Other 510(k) Applications for this Company
Contact	Einat Shammai 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	10/01/2018
Decision Date	06/19/2019
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