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 K231749
Device Name Radio Frequency System
Applicant
Shenzhenshi Sincoheren S&T Development Co., Ltd.
Floor 4, No 2 Plant, # 14, Zhongxing Rd., Xiuxin
Community, Kengzi St., Pingshan District
Shenzhen,  CN 518000
Applicant Contact Cai Jialong
Correspondent
Shenzhenshi Sincoheren S&T Development Co., Ltd.
Floor 4, No 2 Plant, # 14, Zhongxing Rd., Xiuxin
Community, Kengzi St., Pingshan District
Shenzhen,  CN 518000
Correspondent Contact Cai Jialong
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/15/2023
Decision Date 10/19/2023
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
-
-