The following data is part of a premarket notification filed by Medispec, Ltd. with the FDA for Econolith E3000, Model 3000 (sw-6).
| Device ID | K040461 |
| 510k Number | K040461 |
| Device Name: | ECONOLITH E3000, MODEL 3000 (SW-6) |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | MEDISPEC, LTD. 12850 MIDDLEBROOK RD. STE. 1 Germantown, MD 20874 |
| Contact | Sheryl D Skinner |
| Correspondent | Sheryl D Skinner MEDISPEC, LTD. 12850 MIDDLEBROOK RD. STE. 1 Germantown, MD 20874 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-23 |
| Decision Date | 2004-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016498318 | K040461 | 000 |
| 07290016498301 | K040461 | 000 |