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510(k) K191166

Device
DigniCap Delta
Applicant
Dignitana Inc.
510(k) number
K191166
Product code
PMC  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-26
Date received
2019-05-01
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
William Cronin
Address
10925 Estate Ln., Suite W-185 Dallas TX US 75238 75238

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
K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.2021-10-21
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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