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FDA 510(k)

SALINUM, ORCLAIR

K-Number: K024148 · 2003-09-15

ApplicantSinclair Pharmaceuticals, Ltd.
Decision Date2003-09-15
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

SALINUM, ORCLAIR is the device name listed in this FDA 510(k) record. The listed applicant is Sinclair Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2003-09-15 under 510(k) number K024148. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALINUM, ORCLAIR?

SALINUM, ORCLAIR is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Sinclair Pharmaceuticals, Ltd.. The 510(k) number is K024148.

When did SALINUM, ORCLAIR receive FDA 510(k) clearance?

SALINUM, ORCLAIR received FDA 510(k) clearance on 2003-09-15, under 510(k) number K024148.

Who is the listed applicant for SALINUM, ORCLAIR?

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

What is the FDA product code for SALINUM, ORCLAIR?

The FDA product code for SALINUM, ORCLAIR is LFD.

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Other records listing Sinclair Pharmaceuticals, Ltd. as applicant

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.

K050158SINCLAIR SEBORRHEA EMULSIONK042722ALOCLAIR ORAL SPRAYK040950ALOCLAIR ORAL GELK024367SINCLAIR WOUND AND SKIN EMULSIONK023046SST SALIVA SUPPORTING TABLETSK023155ALOCLAIR ORAL RINSE

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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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