FDA 510(k) Application Details - K240454

Device Classification Name	More FDA Info for this Device
510(K) Number	K240454
Device Name	RESPONDER« Polysaccharide Hemostat
Applicant	Starch Medical, Inc. 2150 Ringwood ave. San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Alice Li 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	02/15/2024
Decision Date	03/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review