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 K223784
Device Name Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
Applicant
Deltronix Equipamentos Ltda
Rua Barao De Cotegipe, 776
Ribeirao Preto,  BR 14050-420
Applicant Contact Carlos Paulim
Correspondent
Pr Serviços Regulatórios Administrativos Ltda
Rua Alice Aem Saadi, 855/ 2404
Ribeirao Pret,  BR 14096-570
Correspondent Contact Bruno Milhoci
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/16/2022
Decision Date 04/18/2023
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
-
-