Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K212277 |
Device Name |
Tempo Tampon |
Applicant |
Dong-A Pharmaceutical Co., Ltd. |
64 Cheonho-daero, Dongdaemun-gu |
Seoul,
KR
02587
|
|
Applicant Contact |
Hyunjeong Jang |
Correspondent |
Provision Consulting Group, Inc. |
100 N. Barranca St. Suite 700 |
West Covina,
CA
91791
|
|
Correspondent Contact |
Joyce Kwon |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 07/20/2021 |
Decision Date | 04/21/2022 |
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
|
|
|