Device Classification Name |
cup, menstrual
|
510(k) Number |
K920792 |
Device Name |
SOFTCUP(TM):2 |
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 | 02/21/1992 |
Decision Date | 10/05/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|