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 | Decision date |
|---|---|---|---|
| K855146 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL | Laserscope | 1986-04-11 |
Legacy Summary#
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FDA Review#
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