Device Classification Name |
System, Monitoring, Perinatal
|
510(k) Number |
K910418 |
Device Name |
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 |
Applicant |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1274 |
BUFFALO,
NY
14240
|
|
Applicant Contact |
VAN DINE |
Correspondent |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1274 |
BUFFALO,
NY
14240
|
|
Correspondent Contact |
VAN DINE |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 01/30/1991 |
Decision Date | 07/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|