Device Classification Name |
Instrument, Manual, Specialized Obstetric-Gynecologic
|
510(k) Number |
K954619 |
Device Name |
CORDGUARD II |
Applicant |
UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST |
MIDVALE,
UT
84047 -1048
|
|
Applicant Contact |
KEVIN L CORNWELL |
Correspondent |
UTAH MEDICAL PRODUCTS, INC. |
7043 SOUTH 300 WEST |
MIDVALE,
UT
84047 -1048
|
|
Correspondent Contact |
KEVIN L CORNWELL |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 10/05/1995 |
Decision Date | 12/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|