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FDA 510(k)

GELCLAIR CONCENTRATED ORAL GEL

K-Number: K013056 · 2001-12-21

ApplicantSinclair Pharmaceuticals, Ltd.
Decision Date2001-12-21
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

GELCLAIR CONCENTRATED ORAL GEL 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 2001-12-21 under 510(k) number K013056. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELCLAIR CONCENTRATED ORAL GEL?

GELCLAIR CONCENTRATED ORAL GEL is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Sinclair Pharmaceuticals, Ltd.. The 510(k) number is K013056.

When did GELCLAIR CONCENTRATED ORAL GEL receive FDA 510(k) clearance?

GELCLAIR CONCENTRATED ORAL GEL received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013056.

Who is the listed applicant for GELCLAIR CONCENTRATED ORAL GEL?

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 GELCLAIR CONCENTRATED ORAL GEL?

The FDA product code for GELCLAIR CONCENTRATED ORAL GEL is OLR.

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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 GELK024148SALINUM, ORCLAIRK024367SINCLAIR WOUND AND SKIN EMULSIONK023046SST SALIVA SUPPORTING TABLETS

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, 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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