FDA.reportPublic FDA data

510(k) K870773

Device
ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
Applicant
HGM, INC.
510(k) number
K870773
Product code
LLF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-10
Date received
1987-02-26
Regulation
510(k) Premarket Notification
Classification name
Laser, Neurosurgical, Argon
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Neurology
Device class
3
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DENNIS REIGLE
Address
3959 W. 1820 S. Salt Lake City UT US 84104 84104

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864610CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USEInframed, Inc.1987-06-18
K860977MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATIONBritt Corp., Inc.1986-10-16
K833497COOPER MEDICAL MODEL 770Cooper Medical Corp.1984-04-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases