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 electrosurgical, cutting & coagulation & accessories
510(k) Number K203522
Device Name Surn5 Electrosurgical Argon Beam Generator and Accessories
Applicant
Surnic Corporation
480 Apollo Street, Suite D.
Brea,  CA  92821
Applicant Contact Helen Xie
Correspondent
Surnic Corporation
480 Apollo Street, Suite D.
Brea,  CA  92821
Correspondent Contact Helen Xie
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/01/2020
Decision Date 02/22/2021
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
-
-