The following data is part of a premarket notification filed by Medispec, Ltd. with the FDA for Lithospec(tm) Intracorporeal Lithotripter.
| Device ID | K974796 |
| 510k Number | K974796 |
| Device Name: | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MEDISPEC, LTD. 19110 MONTGOMERY VILLAGE AVE. SUITE 100 Montgomery Village, MD 20886 |
| Contact | Avner Spector |
| Correspondent | Avner Spector MEDISPEC, LTD. 19110 MONTGOMERY VILLAGE AVE. SUITE 100 Montgomery Village, MD 20886 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-03-12 |
| Summary: | summary |