Device Classification Name |
tampon, menstrual, scented, deodorized
|
510(k) Number |
K862353 |
Device Name |
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION) |
Applicant |
TAMBRANDS, INC. |
BRIDGE & SPRINGFIELD STREETS |
PALMER,
MA
01069
|
|
Applicant Contact |
ROBERT J STAAB |
Correspondent |
TAMBRANDS, INC. |
BRIDGE & SPRINGFIELD STREETS |
PALMER,
MA
01069
|
|
Correspondent Contact |
ROBERT J STAAB |
Regulation Number | 884.5460
|
Classification Product Code |
|
Date Received | 06/20/1986 |
Decision Date | 07/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|