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)

SKIN TECH. ISOTEX 86L

K-Number: K840609 · 1984-10-31

ApplicantLectec Corp.
Decision Date1984-10-31
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN TECH. ISOTEX 86L is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K840609. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN TECH. ISOTEX 86L?

SKIN TECH. ISOTEX 86L is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Lectec Corp.. The 510(k) number is K840609.

When did SKIN TECH. ISOTEX 86L receive FDA 510(k) clearance?

SKIN TECH. ISOTEX 86L received FDA 510(k) clearance on 1984-10-31, under 510(k) number K840609.

Who is the listed applicant for SKIN TECH. ISOTEX 86L?

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

What is the FDA product code for SKIN TECH. ISOTEX 86L?

The FDA product code for SKIN TECH. ISOTEX 86L is KGX.

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 Lectec Corp. 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.

K950943ULTRA EASEK925384ISOPORE(TM) TAPE, MODIFICATIONK930258TRACET T-6000K923558ECG ELECTRODEK922959ISOPORE TAPEK912450TRACETS SME 5000

View all 27 devices →

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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.

↑