Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K971303 |
Device Name |
INSTEAD, SOFTCUP |
Applicant |
ULTRAFEM, INC. |
1050 CONNECTICUT AVE., N.W. |
WASHINGTON,
DC
20036 -5339
|
|
Applicant Contact |
PETER S REICHERTZ |
Correspondent |
ULTRAFEM, INC. |
1050 CONNECTICUT AVE., N.W. |
WASHINGTON,
DC
20036 -5339
|
|
Correspondent Contact |
PETER S REICHERTZ |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 04/08/1997 |
Decision Date | 06/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|