Device Classification Name |
Monitor, Pressure, Intrauterine
|
510(k) Number |
K950498 |
Device Name |
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER |
Applicant |
GRAPHIC CONTROLS CORP. |
PO BOX 1274 |
189 VAN RENSSELAER STREET |
BUFFALO,
NY
14240
|
|
Applicant Contact |
IGNATY GUSAKOV |
Correspondent |
GRAPHIC CONTROLS CORP. |
PO BOX 1274 |
189 VAN RENSSELAER STREET |
BUFFALO,
NY
14240
|
|
Correspondent Contact |
IGNATY GUSAKOV |
Regulation Number | 884.2700
|
Classification Product Code |
|
Date Received | 02/06/1995 |
Decision Date | 07/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|