510(k) Premarket Notification Database
Device Classification Name |
tampon, menstrual, scented, deodorized
|
510(k) Number | K896115 |
Device Name | TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER |
Applicant |
TAMBRANDS, INC.
|
bridge & springfield streets |
palmer,
MA
01069 |
|
Contact | davis, phd |
Regulation Number | 884.5460 |
Classification Product Code |
|
Date Received | 10/23/1989 |
Decision Date | 12/13/1989 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Obstetrics/Gynecology
|
Review Advisory Committee |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|