Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K231341 |
Device Name |
Organic cotton tampon, Viscose tampon |
Applicant |
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. |
Lianshi Industrial Park, Nanxun District |
Huzhou,
CN
313013
|
|
Applicant Contact |
Roy Du |
Correspondent |
Shenzhen Joyantech Consulting Co. Ltd |
1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan |
District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Grace Liu |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 05/09/2023 |
Decision Date | 08/14/2023 |
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
|
|
|