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FDA 510(k)

Rael Tampon

K-Number: K182814 · 2019-07-15

ApplicantRael, Inc.
Decision Date2019-07-15
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Rael Tampon is a medical device manufactured by Rael, Inc.. It received FDA 510(k) clearance on 2019-07-15 under approval number K182814. 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 Rael Tampon?

Rael Tampon is a medical device that received FDA 510(k) clearance on 2019-07-15. It is manufactured by Rael, Inc.. The 510(k) number is K182814.

When was Rael Tampon approved by the FDA?

Rael Tampon received FDA 510(k) clearance on 2019-07-15, under approval number K182814.

What company makes Rael Tampon?

Rael Tampon is manufactured by Rael, Inc..

What is the FDA product code for Rael Tampon?

The FDA product code for Rael 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.

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