TOSAMA Reusable Applicator
K-Number: K232060 · 2024-04-12
ApplicantTosama, D.O.O.
Decision Date2024-04-12
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
TOSAMA Reusable Applicator is a medical device manufactured by Tosama, D.O.O.. It received FDA 510(k) clearance on 2024-04-12 under approval number K232060. 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 TOSAMA Reusable Applicator?
TOSAMA Reusable Applicator is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Tosama, D.O.O.. The 510(k) number is K232060.
When was TOSAMA Reusable Applicator approved by the FDA?
TOSAMA Reusable Applicator received FDA 510(k) clearance on 2024-04-12, under approval number K232060.
What company makes TOSAMA Reusable Applicator?
TOSAMA Reusable Applicator is manufactured by Tosama, D.O.O..
What is the FDA product code for TOSAMA Reusable Applicator?
The FDA product code for TOSAMA Reusable Applicator 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.