Device Classification Name |
table, obstetric (and accessories)
|
510(k) Number |
K903973 |
Device Name |
GARDOSI BIRTHING CUSHION |
Applicant |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1274 |
BUFFALO,
NY
14240
|
|
Applicant Contact |
ALBERT AMELOTTE |
Correspondent |
GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. |
P.O. BOX 1274 |
BUFFALO,
NY
14240
|
|
Correspondent Contact |
ALBERT AMELOTTE |
Regulation Number | 884.4900
|
Classification Product Code |
|
Date Received | 08/28/1990 |
Decision Date | 09/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|