FDA 510(k) Application Details - K183190

Device Classification Name	More FDA Info for this Device
510(K) Number	K183190
Device Name	NuStat
Applicant	Beeken Biomedical, LLC 378 Page St, Suite 201 Stoughton, MA 02072 US Other 510(k) Applications for this Company
Contact	Richard A. Kendall Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2018
Decision Date	09/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review