Self Sealing Sterilization Pouches
K-Number: K243721 · 2025-04-25
Decision Date2025-04-25
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Self Sealing Sterilization Pouches is a medical device manufactured by Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under approval number K243721. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Self Sealing Sterilization Pouches?
Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K243721.
When was Self Sealing Sterilization Pouches approved by the FDA?
Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2025-04-25, under approval number K243721.
What company makes Self Sealing Sterilization Pouches?
Self Sealing Sterilization Pouches is manufactured by Wellmed Dental Medical Supply Co., Ltd..
What is the FDA product code for Self Sealing Sterilization Pouches?
The FDA product code for Self Sealing Sterilization Pouches is FRG.
Other Devices by Wellmed Dental Medical Supply Co., Ltd.
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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.