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FDA 510(k)

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL

K-Number: K073684 · 2008-05-22

ApplicantSheffield Industries, Div. of Faria , Ltd.
Decision Date2008-05-22
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL is the device name listed in this FDA 510(k) record. The listed applicant is Sheffield Industries, Div. of Faria , Ltd.. It received FDA 510(k) clearance on 2008-05-22 under 510(k) number K073684. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL?

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL is a medical device that received FDA 510(k) clearance on 2008-05-22. The listed applicant is Sheffield Industries, Div. of Faria , Ltd.. The 510(k) number is K073684.

When did SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL receive FDA 510(k) clearance?

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL received FDA 510(k) clearance on 2008-05-22, under 510(k) number K073684.

Who is the listed applicant for SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL?

The FDA 510(k) record lists Sheffield Industries, Div. of Faria , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL?

The FDA product code for SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL is KMJ.

Related Clinical Trials

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.

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Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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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