510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820018Substantially Equivalent

Comfeel Protective Sheet

Telecam Medical Devices, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820018 is the FDA 510(k) clearance record for COMFEEL PROTECTIVE SHEET, a class I device, cleared for Telecam Medical Devices on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list one 510(k) clearance for Telecam Medical Devices. As of , FDA records show no recalls naming K820018.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Telecam Medical Devices 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KGX

Trailing 12 months

FDA records hold no clearances under product code KGX in the trailing twelve months.

FDA records show no clearances under product code KGX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260