Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K201260
Device Name Dermal Cooling System
Applicant
R2 Technologies, Inc.
2603 Camino Ramon, Suite 200
San Ramon,  CA  94583
Applicant Contact Ragan Reppond
Correspondent
R2 Technologies, Inc.
2603 Camino Ramon, Suite 200
San Ramon,  CA  94583
Correspondent Contact Ragan Reppond
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received05/11/2020
Decision Date 09/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-