ReminGel
FDA 510(k) K241489 · Inter-Med, Inc.
510(k) numberK241489
Submission
- Device name
- ReminGel
- Applicant
- Inter-Med, Inc.
Racine, WI, US - Received
- May 24, 2024
- Decision date
- January 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
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Questions and answers
When was ReminGel cleared by the FDA?
ReminGel (K241489) received a 510(k) decision of Substantially Equivalent on January 8, 2025, 229 days after the submission was received.
What is the product code of K241489?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.