FDA 510(k) Application Details - K183436

Device Classification Name	Oral Wound Dressing   More FDA Info for this Device
510(K) Number	K183436
Device Name	Oral Wound Dressing
Applicant	TBM Corporation B-301, Gwangju High-tech Center, 313, Cheomadangwagi-ro, Buk-gu Gwangju 61008 KR Other 510(k) Applications for this Company
Contact	Jae-woong Jeong Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2018
Decision Date	09/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review