Skip to content

Deroyal Industries, Inc. Polyderm & Polyderm Border Foam Wound Dressings

by Deroyal Industries, Inc.

510(k) K953403

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK953403 Date6 Oct 1995DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
SN

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →