• 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 electrocautery, gynecologic (and accessories)
510(k) Number K930132
Device Name LEEP AND LLETZ ELECTRODES
Applicant
NORDEX MEDICAL CORP.
3417 ROGER B. CHAFFEE BLVD.,
SUITE 309
GRAND RAPIDS,  MI  49548
Applicant Contact JAY T BAATZ
Correspondent
NORDEX MEDICAL CORP.
3417 ROGER B. CHAFFEE BLVD.,
SUITE 309
GRAND RAPIDS,  MI  49548
Correspondent Contact JAY T BAATZ
Regulation Number884.4120
Classification Product Code
HGI  
Date Received01/12/1993
Decision Date 05/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-