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510(k) K211526

Device
Portable Scalp Cooling System
Applicant
Cooler Heads Care, Inc.
510(k) number
K211526
Product code
PMC  
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-21
Date received
2021-05-17
Regulation
878.4360
Classification name
Scalp Cooling System
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Dilligan
Address
2801 B St., #209 San Diego CA US 92102 92102

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PMC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited2025-11-25
K191166DigniCap DeltaDignitana, Inc.2019-06-26
K173032Paxman Scalp CoolerPaxman Coolers Limited2018-06-07
K170871DigniCap Scalp Cooling SystemDignitana AB2017-07-03
K163484Paxman Scalp CoolerPaxman Coolers Limited2017-04-17
DEN150010Dignitana AB DigniCap SystemDignitana AB2015-12-08

Legacy Summary#

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FDA Review#

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