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FDA 510(k)

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray

K-Number: K181839 · 2019-11-21

ApplicantOralabs, Inc.
Decision Date2019-11-21
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray is the device name listed in this FDA 510(k) record. The listed applicant is Oralabs, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K181839. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray?

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Oralabs, Inc.. The 510(k) number is K181839.

When did CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray receive FDA 510(k) clearance?

CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray received FDA 510(k) clearance on 2019-11-21, under 510(k) number K181839.

Who is the listed applicant for CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray?

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

What is the FDA product code for CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray?

The FDA product code for CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray is LFD.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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