FDA 510(k) Application Details - K211026

Device Classification Name	More FDA Info for this Device
510(K) Number	K211026
Device Name	Minitube Dentasleeve Protective Barrier Sleeves
Applicant	Minitube AB ByvΣgen 44 Trσngsviken 83596 SE Other 510(k) Applications for this Company
Contact	Bengt Myhrman 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	04/06/2021
Decision Date	08/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review