The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm, Inc. Lasercath (sterile).
Device ID | K860357 |
510k Number | K860357 |
Device Name: | HGM, INC. LASERCATH (STERILE) |
Classification | Laser For Gastro-urology Use |
Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Greg Mcarthur |
Correspondent | Greg Mcarthur HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-30 |
Decision Date | 1986-04-07 |