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Hyalomatrix Co

by Fidia Advanced Biopolymers Srl 510(k)

Active United States

510(k) K003855

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003855 Date3 Jul 2001ClearedStatusActive

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  • Withdrawn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
KHJ
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Fidia Advanced Biopolymers Srl

  • Jaloskin

    Unclassified

  • Laserskin Dressing

    Unclassified

  • Hyalomatrix Pa

    Unclassified