The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Model Pc Argon Laser.
Device ID | K880908 |
510k Number | K880908 |
Device Name: | MODEL PC ARGON LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Bill Papworth |
Correspondent | Bill Papworth HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-03 |
Decision Date | 1988-05-03 |