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'exmoor' Shah Silicone Discs

by Exmoor Plastics Limited United Kingdom 510(k)

510(k) K864934

Product code EPP

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864934 Date28 Jan 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

510(k) · synced 23 Oct 2026

510(k) Number
FDA Product Code
EPP
FDA applicant
Exmoor Plastics , Ltd.
Device Class
Class I
Regulation
21 CFR Part 874.5800
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Exmoor Plastics Limited

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K864934 24 fields · synced 23 Oct 2026