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 Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K941207
Device Name MONOPOLAR SUCTION CANNULA; MONOPOLAR ELECTRODES
Applicant
New Eder Corp.
1451-E Landmeier Rd.
Elk Groove Village,  IL  60007
Applicant Contact JAIRO E CANAVERAL
Correspondent
New Eder Corp.
1451-E Landmeier Rd.
Elk Groove Village,  IL  60007
Correspondent Contact JAIRO E CANAVERAL
Regulation Number884.4160
Classification Product Code
KNF  
Date Received03/14/1994
Decision Date 01/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-