Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K180167 |
Device Name |
Playtex Stella Tampons |
Applicant |
Playtex Manufacturing, Inc. |
804 Walker Road |
Dover,
DE
19904
|
|
Applicant Contact |
Ludjane Fiorillo |
Correspondent |
Edgewell Personal Care |
75 Commerce Drive |
Allendale,
NJ
07401
|
|
Correspondent Contact |
Danielle Vitale |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 01/22/2018 |
Decision Date | 05/30/2018 |
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
|
|
|