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 K132224
Device Name UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
Applicant
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  33777
Applicant Contact LEE ALEXANDER
Correspondent
Unimed Surgical Products, Inc.
10401 Belcher Rd.
Largo,  FL  33777
Correspondent Contact LEE ALEXANDER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/17/2013
Decision Date 10/08/2013
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
-
-