Device Classification Name |
Pad, Menstrual, Unscented
|
510(k) Number |
K951693 |
Device Name |
CARESS SANITARY NAPKIN |
Applicant |
STERLING U.S.A., INC. |
90 RONZO RD. |
BRISTOL,
CT
06010
|
|
Applicant Contact |
CAROL FOSTER |
Correspondent |
STERLING U.S.A., INC. |
90 RONZO RD. |
BRISTOL,
CT
06010
|
|
Correspondent Contact |
CAROL FOSTER |
Regulation Number | 884.5435
|
Classification Product Code |
|
Date Received | 04/12/1995 |
Decision Date | 07/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|