The following data is part of a premarket notification filed by Quantel Medical with the FDA for Athos Laser.
Device ID | K020072 |
510k Number | K020072 |
Device Name: | ATHOS LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | QUANTEL MEDICAL 342 SUNSET BAY RD. Hot Springs, AR 71913 |
Contact | Roger W Barnes |
Correspondent | Roger W Barnes QUANTEL MEDICAL 342 SUNSET BAY RD. Hot Springs, AR 71913 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-09 |
Decision Date | 2002-04-09 |
Summary: | summary |