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 K191064
Device Name Argon Handset
Applicant
New Deantronics Taiwan , Ltd.
12f, # 51, Sec. 4, Chong Yang Rd., Tucheng Dist.,
New Taipei City,  TW 23675
Applicant Contact Jane Liu
Correspondent
Coombs Medical Device Consulting, Inc.
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact Craig J. Coombs
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/22/2019
Decision Date 06/12/2019
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
-
-