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Reuter Bobbin Ventila. Tube-Titanium

by Richard'S Medical Equip., Inc.

510(k) K820362

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

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

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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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