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 Prosthesis, Nose, Internal
510(k) Number K241253
Device Name Medicon Epiplating System
Applicant
Cmf Medicon Surgical, Inc.
11200 St. Johns Industrial Pkwy. N. Suite 1
Jacksonville,  FL  32246
Applicant Contact Matthias Alber
Correspondent
Cmf Medicon Surgical, Inc.
11200 St. Johns Industrial Pkwy. N. Suite 1
Jacksonville,  FL  32246
Correspondent Contact Matthias Alber
Regulation Number878.3680
Classification Product Code
FZE  
Date Received05/03/2024
Decision Date 12/12/2024
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
-
-