COMFEEL SEASORB DRESSING— 510(k) K983519

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K983519 for COMFEEL SEASORB DRESSING, Substantially Equivalent on 1998-12-30. Applicant: Coloplast Corp.. Device class: 1.

Clearance details

Applicant: Coloplast Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1998-10-08
Decision date: 1998-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMF

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 Coloplast Corp.

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