Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAXILUBE

K-Number: K943010 · 1995-07-19

ApplicantMission Pharmacal Co.
Decision Date1995-07-19
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXILUBE is the device name listed in this FDA 510(k) record. The listed applicant is Mission Pharmacal Co.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K943010. 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 MAXILUBE?

MAXILUBE is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Mission Pharmacal Co.. The 510(k) number is K943010.

When did MAXILUBE receive FDA 510(k) clearance?

MAXILUBE received FDA 510(k) clearance on 1995-07-19, under 510(k) number K943010.

Who is the listed applicant for MAXILUBE?

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

What is the FDA product code for MAXILUBE?

The FDA product code for MAXILUBE 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 Mission Pharmacal Co. 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.

K901223VACUUM ERECTION DEVICE (VED)K843382UROCYSTIN

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.

↑