Sequel Tampon with Plastic Applicator
K-Number: K230419 · 2023-08-03
ApplicantTampro, Inc.
Decision Date2023-08-03
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Sequel Tampon with Plastic Applicator is a medical device manufactured by Tampro, Inc.. It received FDA 510(k) clearance on 2023-08-03 under approval number K230419. 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 Sequel Tampon with Plastic Applicator?
Sequel Tampon with Plastic Applicator is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Tampro, Inc.. The 510(k) number is K230419.
When was Sequel Tampon with Plastic Applicator approved by the FDA?
Sequel Tampon with Plastic Applicator received FDA 510(k) clearance on 2023-08-03, under approval number K230419.
What company makes Sequel Tampon with Plastic Applicator?
Sequel Tampon with Plastic Applicator is manufactured by Tampro, Inc..
What is the FDA product code for Sequel Tampon with Plastic Applicator?
The FDA product code for Sequel Tampon with Plastic 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.