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510(k) K203006

Device
R2 Dermabrasion Tip (for Dermal Cooling System)
Applicant
R2 Technologies, Inc.
510(k) number
K203006
Product code
QPZ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-05
Date received
2020-10-01
Regulation
878.4340
Classification name
Contact Cooling For Skin Lesion Pain Relief
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
Ragan Reppond
Address
2603 Camino Ramon, Suite 200 San Ramon CA US 94583 94583

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213294Dermal Cooling SystemR2 Technologies, Inc.2022-11-10

Legacy Summary#

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FDA Review#

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