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FDA 510(k)

DUKAL LUBRICATING JELLY

K-Number: K113689 · 2012-05-04

ApplicantDukal Corporation
Decision Date2012-05-04
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUKAL LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corporation. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K113689. 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 DUKAL LUBRICATING JELLY?

DUKAL LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is Dukal Corporation. The 510(k) number is K113689.

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

DUKAL LUBRICATING JELLY received FDA 510(k) clearance on 2012-05-04, under 510(k) number K113689.

Who is the listed applicant for DUKAL LUBRICATING JELLY?

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

What is the FDA product code for DUKAL LUBRICATING JELLY?

The FDA product code for DUKAL LUBRICATING JELLY is KMJ.

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Other records listing Dukal 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.

K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownK210321Dukal Corporation Level 1 Pediatric Face MaskK203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical GownK201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnK201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie OnsK070692DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK

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.K112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA 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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