The following data is part of a premarket notification filed by Laurimed Llc with the FDA for Laurimed Percutaneous Discectomy System, Model Fg-000002.
| Device ID | K082194 |
| 510k Number | K082194 |
| Device Name: | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 |
| Classification | Arthroscope |
| Applicant | LAURIMED LLC 500 ARGUELLO STREET, SUITE 100 Redwood City, CA 94063 |
| Contact | Nancy Lince |
| Correspondent | Nancy Lince LAURIMED LLC 500 ARGUELLO STREET, SUITE 100 Redwood City, CA 94063 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2008-08-28 |
| Summary: | summary |