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 Number | 884.4120
|
Classification Product Code |
|
Date Received | 01/12/1993 |
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
|
|
|