SEK — Wound Dressings With Hydrocortisone Class U

FDA Device Classification

FDA product code SEK covers "Wound Dressings With Hydrocortisone", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
SEK
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
No

Definition

A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K883566minnetonkaMEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GELSeptember 1, 1989
K883619minnetonkaMEDICATED COVERING COATED W/1.0% HYDRO ADHES. GELSeptember 1, 1989