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Nagashima Nx-150F Light Source Unit

by Kelleher Corp. 510(k)

Active United States

510(k) K821710

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821710 Date25 Jun 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EQN
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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