KALTOGEL WOUND DRESSING— 510(k) K940407

Name: FDA 510(k) clearance K940407
Creator: U.S. Food and Drug Administration
Published: 1994-04-07

Substantially Equivalent for Some Indications

Calgon Corp.

FDA 510(k) clearance K940407 for KALTOGEL WOUND DRESSING, Substantially Equivalent for Some Indications on 1994-04-07. Applicant: Calgon Corp.. Device class: 1.

Clearance details

Applicant: Calgon Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1994-01-27
Decision date: 1994-04-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMF

view all

K241916 — TearRepair Liquid Skin Protectant2024-09-27
K182733 — Rochal Bioshield Silicone Film2019-06-27
K171148 — Aleo BME Liquid Bandage2018-01-12
K153571 — Cavilon Advanced High Endurance Skin Protectant2016-08-23
K160684 — Atteris No-Sting Skin Protectant2016-07-26

More clearances from Calgon Corp.

view all

K944950 — KLENZYME1994-12-20
K943364 — CORASSIST WOUND DRESSING1994-08-03
K940263 — NPH-KLENZ1994-05-18
K935063 — INSTRU KLENZ1994-05-09

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