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FDA 510(k)

SINCLAIR SEBORRHEA EMULSION

K-Number: K050158 · 2006-10-11

ApplicantSinclair Pharmaceuticals, Ltd.
Decision Date2006-10-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SINCLAIR SEBORRHEA EMULSION 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 2006-10-11 under 510(k) number K050158. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINCLAIR SEBORRHEA EMULSION?

SINCLAIR SEBORRHEA EMULSION is a medical device that received FDA 510(k) clearance on 2006-10-11. The listed applicant is Sinclair Pharmaceuticals, Ltd.. The 510(k) number is K050158.

When did SINCLAIR SEBORRHEA EMULSION receive FDA 510(k) clearance?

SINCLAIR SEBORRHEA EMULSION received FDA 510(k) clearance on 2006-10-11, under 510(k) number K050158.

Who is the listed applicant for SINCLAIR SEBORRHEA EMULSION?

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 SINCLAIR SEBORRHEA EMULSION?

The FDA product code for SINCLAIR SEBORRHEA EMULSION is FRO. This falls under the Anesthesiology category.

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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.

K042722ALOCLAIR ORAL SPRAYK040950ALOCLAIR ORAL GELK024148SALINUM, ORCLAIRK024367SINCLAIR WOUND AND SKIN EMULSIONK023046SST SALIVA SUPPORTING TABLETSK023155ALOCLAIR ORAL RINSE

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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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