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FDA 510(k)

KENTEX

K-Number: K953914 · 1995-11-06

ApplicantKentron Health Care, Inc.
Decision Date1995-11-06
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

KENTEX is the device name listed in this FDA 510(k) record. The listed applicant is Kentron Health Care, Inc.. It received FDA 510(k) clearance on 1995-11-06 under 510(k) number K953914. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENTEX?

KENTEX is a medical device that received FDA 510(k) clearance on 1995-11-06. The listed applicant is Kentron Health Care, Inc.. The 510(k) number is K953914.

When did KENTEX receive FDA 510(k) clearance?

KENTEX received FDA 510(k) clearance on 1995-11-06, under 510(k) number K953914.

Who is the listed applicant for KENTEX?

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

What is the FDA product code for KENTEX?

The FDA product code for KENTEX is EFQ.

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 Kentron Health Care, 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.

K030693KENTEX DISPOSABLE VAGINAL SPECULUMK972410IMPERVIOUS ISOLATION GOWNK971917KENTRON'S ISOLATION GOWNK953465KENTEMPK953830KENSORB

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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