The following data is part of a premarket notification filed by Teknomed, Inc. with the FDA for Technomed Pulsolith 4000 Laser System.
| Device ID | K925395 |
| 510k Number | K925395 |
| Device Name: | TECHNOMED PULSOLITH 4000 LASER SYSTEM |
| Classification | Medical Computers And Software |
| Applicant | TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Contact | Jean-luc Boulnois |
| Correspondent | Jean-luc Boulnois TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-26 |
| Decision Date | 1993-05-21 |