The following data is part of a premarket notification filed by Teknomed, Inc. with the FDA for Technomed Pulsolith Laser System.
| Device ID | K890436 |
| 510k Number | K890436 |
| Device Name: | TECHNOMED PULSOLITH LASER SYSTEM |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Contact | Richard Hunter |
| Correspondent | Richard Hunter TEKNOMED, INC. NORTH WOODS BUSINESS PARK 99 ROSEWOOD DRIVE, SUITE 140 Danvers, MA 01923 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-03-23 |