COMFEEL PROTECTIVE SHEET— 510(k) K820018

Name: FDA 510(k) clearance K820018
Creator: U.S. Food and Drug Administration
Published: 1982-02-04

Substantially Equivalent

Telecam Medical Devices

FDA 510(k) clearance K820018 for COMFEEL PROTECTIVE SHEET, Substantially Equivalent on 1982-02-04. Applicant: Telecam Medical Devices. Device class: 1.

Clearance details

Applicant: Telecam Medical Devices
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1982-01-05
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGX

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K001240 — SERAGARD INJECTION PATCH2000-06-21
K983368 — CARE BAND ANTIBACTERIAL BANDAGES1999-02-17
K972914 — SYVEK PATCH1997-12-22
K943314 — ADHESIVE BANDAGES WITH OTC DRUG1996-01-17
K952606 — TARGETT PATCH1995-12-21

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.