The following data is part of a premarket notification filed by Suzhou Borage Medical Technology Co., Ltd. with the FDA for Unscented Menstrual Tampon.
Device ID | K222046 |
510k Number | K222046 |
Device Name: | Unscented Menstrual Tampon |
Classification | Tampon, Menstrual, Unscented |
Applicant | Suzhou Borage Medical Technology Co., Ltd. No.9, Shiheshan Road, Dongshan Town, Wuzhong District Suzhou, CN 215107 |
Contact | Zhou Nana |
Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, CN 518000 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-07-11 |
Decision Date | 2022-09-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840117328440 | K222046 | 000 |
08401173284198 | K222046 | 000 |
00840117328471 | K222046 | 000 |
08401173287854 | K222046 | 000 |
00810180840200 | K222046 | 000 |
00810180840651 | K222046 | 000 |