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Shea Locking Bail Prosthesis

by Richard'S Medical Equip., Inc. 510(k)

Active United States

510(k) K802873

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802873 Date19 Dec 1980ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ETB
Device Class
Class II
Regulation
21 CFR Part 874.3450
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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