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FDA 510(k)

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist

K-Number: K173237 · 2018-03-19

ApplicantSyendgen, Inc.
Decision Date2018-03-19
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist is the device name listed in this FDA 510(k) record. The listed applicant is Syendgen, Inc.. It received FDA 510(k) clearance on 2018-03-19 under 510(k) number K173237. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist?

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist is a medical device that received FDA 510(k) clearance on 2018-03-19. The listed applicant is Syendgen, Inc.. The 510(k) number is K173237.

When did Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist receive FDA 510(k) clearance?

Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist received FDA 510(k) clearance on 2018-03-19, under 510(k) number K173237.

Who is the listed applicant for Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist?

The FDA 510(k) record lists Syendgen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist?

The FDA product code for Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist is LFD.

Related Clinical Trials

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Related Devices (Code: LFD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253778Allday Moisturizing RinseElevate Oral CareK250390CloSYS® Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.K240508Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)Laclede, Inc.K234015Caphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) LimitedK231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLCK202689Dentilube SprayOxy2plus, LLC

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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