Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K955093 |
Device Name |
ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 |
Applicant |
UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST |
MIDVALE,
UT
84047 -1048
|
|
Applicant Contact |
JONH W SMITH |
Correspondent |
UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST |
MIDVALE,
UT
84047 -1048
|
|
Correspondent Contact |
JONH W SMITH |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 11/07/1995 |
Decision Date | 04/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|