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Comfeel Contour Dressing

by Coloplast A/S

510(k) K920925

Comfeel Contour Dressing is a Class I device made by Coloplast A/S, cleared under FDA 510(k) K920925 on 28 May 1992, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920925 Date28 May 1992ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KMF
Device class
Class I
Regulation
21 CFR Part 880.5090
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KMF (Bandage, Liquid).

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