510(k) K871424

Device
ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER
Applicant
HGM, INC.
510(k) number
K871424
Product code
LMS  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-08
Date received
1987-04-09
Regulation
874.4490
Classification name
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
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 LMS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K855146LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOLLaserscope1986-04-11

Legacy Summary#

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FDA Review#

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