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Modification to 3M Tegaderm Chg Dressing

by 3M Company-3M Health Care

510(k) K080620

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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)SESE Substantially Equivalent · Special NumberK080620 Date19 May 2008ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0038-2025 FDA Class II initiated 14 Aug 2024

    Contamination with foreign substance matter

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  • Withdrawn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
FRO
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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