The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Integra Sl.
| Device ID | K062147 |
| 510k Number | K062147 |
| Device Name: | INTEGRA SL |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Contact | Larisa Gershtein |
| Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-10-20 |
| Summary: | summary |