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 Magnetic Surgical System
510(k) Number K223673
Device Name Surgeon Controlled Arm
Applicant
Levita Magnetics International Corp
4055-A Campbell Ave.
Menlo Park,  CA  94025
Applicant Contact Alberto Rodriguez-Navarro, MD
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsboroguh,  CA  94010
Correspondent Contact Cindy Domecus, RAC (US & EU)
Regulation Number878.4815
Classification Product Code
PNL  
Date Received12/07/2022
Decision Date 08/04/2023
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
-
-