The following data is part of a premarket notification filed by Taebong Co., Ltd with the FDA for Cottonday Tampon.
Device ID | K182817 |
510k Number | K182817 |
Device Name: | CottonDay Tampon |
Classification | Tampon, Menstrual, Unscented |
Applicant | Taebong Co., Ltd 684-2 Illgok-Dong, Buk-Gu Gwangju Gwangyeogsi, KR 61039 |
Contact | Ha Neul Jeong |
Correspondent | Joyce Kwun Provision Consulting Group, Inc. 3350 Shelby St. Ste 200 Ontario, CA 91764 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-03 |
Decision Date | 2019-07-22 |
Summary: | summary |