FDA 510(k) Application Details - K211526

Device Classification Name	More FDA Info for this Device
510(K) Number	K211526
Device Name	Portable Scalp Cooling System
Applicant	Cooler Heads Care, Inc. 2801 B Street, #209 San Diego, CA 92102 US Other 510(k) Applications for this Company
Contact	Kate Dilligan 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	05/17/2021
Decision Date	10/21/2021
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