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FDA 510(k)

LUBRIGLIDE

K-Number: K973557 · 1997-10-10

ApplicantQualis, Inc.
Decision Date1997-10-10
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUBRIGLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Qualis, Inc.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K973557. 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 LUBRIGLIDE?

LUBRIGLIDE is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Qualis, Inc.. The 510(k) number is K973557.

When did LUBRIGLIDE receive FDA 510(k) clearance?

LUBRIGLIDE received FDA 510(k) clearance on 1997-10-10, under 510(k) number K973557.

Who is the listed applicant for LUBRIGLIDE?

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

What is the FDA product code for LUBRIGLIDE?

The FDA product code for LUBRIGLIDE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Qualis, 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.

K050212PERSONAL WARMING JELLYK050211PERSONAL WARMING GELK041129PERSONAL LUBRICATING GELK040085PERSONAL WARMING LUBRICANTK973780PERSONAL LUBRICATING LIQUID

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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