FDA 510(k) Application Details - K171851

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K171851
Device Name	Elastomer, Silicone Block
Applicant	BISTOOL 9, Gwangnaru-ro 6-gil Seongdong-gu Seoul 04796 KR Other 510(k) Applications for this Company
Contact	Eunhyun Bae Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	MIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2017
Decision Date	03/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review