FDA 510(k) Application Details - K220662

Device Classification Name	More FDA Info for this Device
510(K) Number	K220662
Device Name	Disposable Barrier Sleeves
Applicant	Premium Plus (Dongguan) Limited No.1 Industrial Area, Tutang, Changping Dongguan 523581 CN Other 510(k) Applications for this Company
Contact	Jessica Mao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2022
Decision Date	05/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review