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FDA 510(k)

STERI-LUB LUBRICATION GEL

K-Number: K944969 · 1995-02-27

ApplicantHorizon Medical, Inc.
Decision Date1995-02-27
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-LUB LUBRICATION GEL is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Medical, Inc.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K944969. 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 STERI-LUB LUBRICATION GEL?

STERI-LUB LUBRICATION GEL is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Horizon Medical, Inc.. The 510(k) number is K944969.

When did STERI-LUB LUBRICATION GEL receive FDA 510(k) clearance?

STERI-LUB LUBRICATION GEL received FDA 510(k) clearance on 1995-02-27, under 510(k) number K944969.

Who is the listed applicant for STERI-LUB LUBRICATION GEL?

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

What is the FDA product code for STERI-LUB LUBRICATION GEL?

The FDA product code for STERI-LUB LUBRICATION GEL is KMJ.

Related Clinical Trials

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Other records listing Horizon Medical, Inc. 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.

K980171DERMASENSE PLUS DISPERSIVE ELECTRODEK883576HORIZON ORTHOPEDIC PIN PROTECTOR

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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