The following data is part of a premarket notification filed by Karl Storz Lithotripsy-america, Inc. with the FDA for Modulith Lithotripsy, Model Slk For The Fragmentation Of Urinary And Upper Ureteral Calculi.
| Device ID | K010340 |
| 510k Number | K010340 |
| Device Name: | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ LITHOTRIPSY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ LITHOTRIPSY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-05 |
| Decision Date | 2001-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039100254 | K010340 | 000 |