The following data is part of a premarket notification filed by Laurimed Llc with the FDA for Percutaneous Discectomy System.
| Device ID | K090815 |
| 510k Number | K090815 |
| Device Name: | PERCUTANEOUS DISCECTOMY SYSTEM |
| Classification | Arthroscope |
| Applicant | LAURIMED LLC 500 ARGUELLO STREET, SUITE 100 Redwood City, CA 94063 |
| Contact | Sevrina Ciucci |
| Correspondent | Sevrina Ciucci 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 | 2009-03-25 |
| Decision Date | 2009-05-21 |
| Summary: | summary |