Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K161877 |
Device Name |
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl |
Applicant |
FIRST QUALITY HYGIENIC, INC. |
121 NORTH RD. |
McElhattan,
PA
17748
|
|
Applicant Contact |
Melanie Leibowitz |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
DAVE YUNGVIRT |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 07/08/2016 |
Decision Date | 08/05/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|