Unscented Menstrual Tampon

Tampon, Menstrual, Unscented

Suzhou Borage Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Suzhou Borage Medical Technology Co., Ltd. with the FDA for Unscented Menstrual Tampon.

Pre-market Notification Details

Device IDK222046
510k NumberK222046
Device Name:Unscented Menstrual Tampon
ClassificationTampon, Menstrual, Unscented
Applicant Suzhou Borage Medical Technology Co., Ltd. No.9, Shiheshan Road, Dongshan Town, Wuzhong District Suzhou,  CN 215107
ContactZhou Nana
CorrespondentGrace Liu
Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen,  CN 518000
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-11
Decision Date2022-09-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840117328440 K222046 000
08401173284198 K222046 000
00840117328471 K222046 000
08401173287854 K222046 000
00810180840200 K222046 000
00810180840651 K222046 000

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