The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Medlite Laser System.
Device ID | K952636 |
510k Number | K952636 |
Device Name: | MEDLITE LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | CONTINUUM BIOMEDICAL, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
Contact | Laurie A Ridener |
Correspondent | Laurie A Ridener CONTINUUM BIOMEDICAL, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-08 |
Decision Date | 1995-07-31 |