Unscented Tampon
K-Number: K241064 · 2025-01-10
Decision Date2025-01-10
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Unscented Tampon is a medical device manufactured by Shandong Intco Hygiene Products Co., Ltd.. It received FDA 510(k) clearance on 2025-01-10 under approval number K241064. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Unscented Tampon?
Unscented Tampon is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Shandong Intco Hygiene Products Co., Ltd.. The 510(k) number is K241064.
When was Unscented Tampon approved by the FDA?
Unscented Tampon received FDA 510(k) clearance on 2025-01-10, under approval number K241064.
What company makes Unscented Tampon?
Unscented Tampon is manufactured by Shandong Intco Hygiene Products Co., Ltd..
What is the FDA product code for Unscented Tampon?
The FDA product code for Unscented Tampon is HEB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.