Dunrich Tables

FDA 510(k) K800756 · Dunrich, Inc.

Substantially Equivalent

510(k) numberK800756

Submission

Device name
Dunrich Tables
Applicant
Dunrich, Inc.
Mchenry, IL, US
Received
April 4, 1980
Decision date
April 16, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ETF – Unit, Examining/Treatment, Ent
Device class
Class I (low risk)
Regulation
21 CFR 874.5300
Specialty
Ear, Nose, Throat

Other 510(k)s with product code ETF

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K953457Jedmed Spectrum ENT CabinetETF · Traditional Jedmed Instrument Co.08/11/1995SE
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K932470Langgasse 90ETF · Traditional Happersberger Otopront GmbH08/25/1993SE
K911901Maxi Cabinet Optional Built in S6000 Light SourceETF · Traditional Stortz07/26/1991SE
K910781#491 Power Otolaryngoly CH/#498 Proced CTR & AccesETF · Traditional Midmark Corp.05/15/1991SE
K910243Mobile Treatment CartETF · Traditional Jedmed Instrument Co.04/17/1991SE
K896298Jedmed S ChairETF · Traditional Jedmed Instrument Co.01/26/1990SE
K896273Systema ENT CabinetETF · Traditional Jedmed Instrument Co.01/26/1990SE
K881958Jedmed Maxim ENT CabinetETF · Traditional Jedmed Instrument Co.07/15/1988SE
K860940Micromedics Sterile, Disposable ENT Exam KitETF · Traditional Micromedics, Inc.05/02/1986SE

Questions and answers

When was Dunrich Tables cleared by the FDA?

Dunrich Tables (K800756) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 12 days after the submission was received.

What is the product code of K800756?

The FDA product code is ETF – Unit, Examining/Treatment, Ent, a Class I (low risk) device regulated under 21 CFR 874.5300.