The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Modulith Slk Lithotripter.
| Device ID | K011700 |
| 510k Number | K011700 |
| Device Name: | MODULITH SLK LITHOTRIPTER |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Jennifer S Portugal |
| Correspondent | Jennifer S Portugal KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-01 |
| Decision Date | 2002-08-16 |
| Summary: | summary |