The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Endocoagulator Model 5, 8 & 20 Argon Laser.
Device ID | K871424 |
510k Number | K871424 |
Device Name: | ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER |
Classification | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology |
Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Dennis Reigle |
Correspondent | Dennis Reigle HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | LMS |
CFR Regulation Number | 874.4490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-09 |
Decision Date | 1987-07-08 |