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FDA 510(k)

DYNACOR LUBRICATION GEL

K-Number: K103718 · 2011-05-10

ApplicantMedline Industries, Inc.
Decision Date2011-05-10
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DYNACOR LUBRICATION GEL is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2011-05-10 under 510(k) number K103718. 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 DYNACOR LUBRICATION GEL?

DYNACOR LUBRICATION GEL is a medical device that received FDA 510(k) clearance on 2011-05-10. The listed applicant is Medline Industries, Inc.. The 510(k) number is K103718.

When did DYNACOR LUBRICATION GEL receive FDA 510(k) clearance?

DYNACOR LUBRICATION GEL received FDA 510(k) clearance on 2011-05-10, under 510(k) number K103718.

Who is the listed applicant for DYNACOR LUBRICATION GEL?

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

What is the FDA product code for DYNACOR LUBRICATION GEL?

The FDA product code for DYNACOR LUBRICATION GEL is KMJ.

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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 CompanyK101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal CorporationK092488DYNAREX STERILE LUBRICATING JELLYDynarex 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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