FDA 510(k) Application Details - K163484

Device Classification Name	More FDA Info for this Device
510(K) Number	K163484
Device Name	Paxman Scalp Cooler
Applicant	Paxman Coolers Limited International House, Penistone Road, Fenay Bridge Huddersfield HD8 0LE GB Other 510(k) Applications for this Company
Contact	Richard PAXMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	04/17/2017
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