Model 545-45 for Neurological Surgical Application

FDA 510(k) K860977 · Britt Corp., Inc.

Substantially Equivalent

510(k) numberK860977

Submission

Device name
Model 545-45 for Neurological Surgical Application
Applicant
Britt Corp., Inc.
Smithtown, NY, US
Received
March 14, 1986
Decision date
October 16, 1986
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)DeviceApplicantDecision
K870773Endocoagulator Models 5, 8 & 20 Argon LaserLLF · Traditional Hgm, Inc.07/10/1987SE
K864610Cilas Ym 101 Nd:Yag Laser for Neurological UseLLF · Traditional Inframed, Inc.06/18/1987SE
K833497Cooper Medical Model 770LLF · Traditional Cooper Medical Corp.04/17/1984SE

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K860975Model 545-45 Laser for Ear, Nose & ThroatEWG · Traditional 07/18/1986SE
K860974Model 545-45 Laser for Derma., Pod., SurgicalGEX · Traditional 07/07/1986SE
K860277Model 525-25 Watt C02 Laser for Ear, Nose & ThroatEWG · Traditional 05/06/1986SE
K860273Model 525 - 25 Watt CO2 Medical Laser/PodiatryGEX · Traditional 04/23/1986SE
K860278Model 525-25 Watt CO2 Laser for Derma/PlasticGEX · Traditional 04/15/1986SE
K851425Model J25-25 Watt CO2 LaserHHR · Traditional 11/12/1985SE
K840036Fitex · Traditional 10/26/1984SE

Questions and answers

When was Model 545-45 for Neurological Surgical Application cleared by the FDA?

Model 545-45 for Neurological Surgical Application (K860977) received a 510(k) decision of Substantially Equivalent on October 16, 1986, 216 days after the submission was received.

What is the product code of K860977?

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