ENT Mallets

FDA 510(k) K822204 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822204

Submission

Device name
ENT Mallets
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 23, 1982
Decision date
September 17, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GFJ – Mallet, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GFJ

510(k)DeviceApplicantDecision
K85178929-200 to 29-230 Various Bone Mallets(Wihiger, DoyGFJ · Traditional Artiberia06/20/1985SE
K844017Microtens 7757 T.E.N.S. StimulatorGFJ · Traditional Rabar, Inc.11/30/1984SE

More from Rabar, Inc.

510(k)DeviceDecision
K822618Emergency Tracheostomy Instrument SetLJW · Traditional 01/28/1983SE
K822268Nagashima Ns-Iii ElectronystagmographGWN · Traditional 01/28/1983SE
K823083Electrosurgical UnitGEI · Traditional 12/07/1982SE
K823111Nystymograph AccessGNN · Traditional 11/22/1982SE
K822252ENT Treatment UnitsETF · Traditional 11/22/1982SE
K822272Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional 11/10/1982SE
K822017Tympanostomy Tubes & Various TypesETD · Traditional 10/27/1982SE
K822257Various Types of Light Source HandlesEOQ · Traditional 10/26/1982SE
K822259Laryngeal SpatulasEQH · Traditional 10/22/1982SE
K822004Face ShieldsKNT · Traditional 10/20/1982SE

Questions and answers

When was ENT Mallets cleared by the FDA?

ENT Mallets (K822204) received a 510(k) decision of Substantially Equivalent on September 17, 1982, 56 days after the submission was received.

What is the product code of K822204?

The FDA product code is GFJ – Mallet, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.