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Modification to Autoject Mini

by Owen Mumford Ltd

510(k) K000482

Modification to Autoject Mini is a medical device (FDA Class II; FDA product code KZH, Introducer, Syringe Needle) made by Owen Mumford Ltd, cleared under FDA 510(k) K000482 on 6 Mar 2000, 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 NumberK000482 Date6 Mar 2000ClearedStatusActive

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  • Withdrawn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
KZH
FDA applicant
Owen Mumford, Ltd.
Device class
Class II
Regulation
21 CFR Part 880.6920
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code KZH (Introducer, Syringe Needle).

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