Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K990536 |
Device Name |
O.B. TAMPON |
Applicant |
PERSONAL PRODUCTS CO. |
199 GRANDVIEW RD. |
SKILLMAN,
NJ
08558
|
|
Applicant Contact |
RALPH PETRONE |
Correspondent |
PERSONAL PRODUCTS CO. |
199 GRANDVIEW RD. |
SKILLMAN,
NJ
08558
|
|
Correspondent Contact |
RALPH PETRONE |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 02/19/1999 |
Decision Date | 08/31/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|