Device Atlas

Cooper Medical Model 770

Q: What is the product code of K833497?

The FDA product code is LLF – Laser, Neurosurgical, Argon, a Class III (high risk) device.

FDA 510(k) K833497 · Cooper Medical Corp.

Substantially Equivalent

510(k) numberK833497

Submission

Device name: Cooper Medical Model 770
Applicant: Cooper Medical Corp.
Walker, MI, US
Received: October 11, 1983
Decision date: April 17, 1984
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LLF – Laser, Neurosurgical, Argon
Device class: Class III (high risk)

Other 510(k)s with product code LLF

510(k)	Device	Applicant	Decision
K870773	Endocoagulator Models 5, 8 & 20 Argon LaserLLF · Traditional	Hgm, Inc.	07/10/1987SE
K864610	Cilas Ym 101 Nd:Yag Laser for Neurological UseLLF · Traditional	Inframed, Inc.	06/18/1987SE
K860977	Model 545-45 for Neurological Surgical ApplicationLLF · Traditional	Britt Corp., Inc.	10/16/1986SE

More from Britt Corp., Inc.

510(k)	Device	Decision
K840144	Yag Laser 8000 Gastrointestinal BleeFCG · Traditional	05/18/1984SE
K833387	Argon Laser Surgical System 770 · Traditional	04/18/1984SE
K832703	Argon Laser Sys-Model 5000HQE · Traditional	01/30/1984SE
K820261	Monitor CO2 Laser SystemHHR · Traditional	03/05/1982SE

Questions and answers

When was Cooper Medical Model 770 cleared by the FDA?

Cooper Medical Model 770 (K833497) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 189 days after the submission was received.

What is the product code of K833497?

The FDA product code is LLF – Laser, Neurosurgical, Argon, a Class III (high risk) device.