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Reuter Bobbin Ventila. Tube-Titanium

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

Active United States

510(k) K820362

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820362 Date2 Mar 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0797-2010 FDA Unclassified (pre-2012) initiated 8 Jan 2010

    Units of the product in lot MH136952 may have been shipped without being sterilized.

Specification

510(k)

510(k) Number
FDA Product Code
ETD
Device Class
Class II
Regulation
21 CFR Part 874.3880
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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