The following data is part of a premarket notification filed by Dong-a Pharmaceutical Co., Ltd. with the FDA for Tempo Tampon.
| Device ID | K212277 |
| 510k Number | K212277 |
| Device Name: | Tempo Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Dong-A Pharmaceutical Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu Seoul, KR 02587 |
| Contact | Hyunjeong Jang |
| Correspondent | Joyce Kwon Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806011633242 | K212277 | 000 |
| 08806011632863 | K212277 | 000 |