The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Conbio Medalex Laser System.
| Device ID | K935631 |
| 510k Number | K935631 |
| Device Name: | CONBIO MEDALEX 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 | 1993-11-24 |
| Decision Date | 1994-08-23 |