Device Classification Name |
Monitor, Pressure, Intrauterine
|
510(k) Number |
K991235 |
Device Name |
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC) |
Applicant |
LUDLOW TECHNICAL PRODUCTS |
TWO LUDLOW PARK |
CHICOPEE,
MA
01022
|
|
Applicant Contact |
KATHLEEN M MURPHY |
Correspondent |
LUDLOW TECHNICAL PRODUCTS |
TWO LUDLOW PARK |
CHICOPEE,
MA
01022
|
|
Correspondent Contact |
KATHLEEN M MURPHY |
Regulation Number | 884.2700
|
Classification Product Code |
|
Date Received | 04/12/1999 |
Decision Date | 07/08/1999 |
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
|
|
|