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FDA 510(k)

DYNAREX STERILE LUBRICATING JELLY

K-Number: K092488 · 2009-12-18

ApplicantDynarex Corporation
Decision Date2009-12-18
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYNAREX STERILE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corporation. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K092488. 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 DYNAREX STERILE LUBRICATING JELLY?

DYNAREX STERILE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Dynarex Corporation. The 510(k) number is K092488.

When did DYNAREX STERILE LUBRICATING JELLY receive FDA 510(k) clearance?

DYNAREX STERILE LUBRICATING JELLY received FDA 510(k) clearance on 2009-12-18, under 510(k) number K092488.

Who is the listed applicant for DYNAREX STERILE LUBRICATING JELLY?

The FDA 510(k) record lists Dynarex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAREX STERILE LUBRICATING JELLY?

The FDA product code for DYNAREX STERILE LUBRICATING JELLY is KMJ.

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Other records listing Dynarex Corporation 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.

K172266Dynarex Three-Way StopcockK152970Dynarex Xeroform Petrolatum DressingK103086DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRICK102637DYNAREX ULTRASOUND GELK082863DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS

View all 7 devices →

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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