The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Endocoagulator(tm) Model 20 Argon Laser For Urolo..
Device ID | K872630 |
510k Number | K872630 |
Device Name: | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. |
Classification | Laser For Gastro-urology Use |
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 | LNK |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-08-25 |