External Moisturizing Gel
K-Number: K171855 · 2017-07-21
ApplicantCombe Incorporated
Decision Date2017-07-21
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
External Moisturizing Gel is a medical device manufactured by Combe Incorporated. It received FDA 510(k) clearance on 2017-07-21 under approval number K171855. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the External Moisturizing Gel?
External Moisturizing Gel is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Combe Incorporated. The 510(k) number is K171855.
When was External Moisturizing Gel approved by the FDA?
External Moisturizing Gel received FDA 510(k) clearance on 2017-07-21, under approval number K171855.
What company makes External Moisturizing Gel?
External Moisturizing Gel is manufactured by Combe Incorporated.
What is the FDA product code for External Moisturizing Gel?
The FDA product code for External Moisturizing Gel is NUC.
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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.