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Sundash

by Sun Ind., Inc.

510(k) K932483

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932483 Date22 Feb 1994ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2635-2014 FDA Class II initiated 25 Jul 2014

    The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).

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  • Withdrawn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
LEJ
Device Class
Class II
Regulation
21 CFR Part 878.4635
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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