FDA 510(k) Application Details - K161013

Device Classification Name	More FDA Info for this Device
510(K) Number	K161013
Device Name	InnoSEAL Hemostatic Pad
Applicant	InnoTherapy Inc. Ace Hightechcity2,25, Seonyu-ro 13-gil Yeongdeungpo-gu Seoul 07282 KR Other 510(k) Applications for this Company
Contact	Moon Sue Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2016
Decision Date	11/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review