The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Storz Modulith Slk Lithotripter With Multiview Option.
| Device ID | K012482 |
| 510k Number | K012482 |
| Device Name: | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Jennifer Portugal |
| Correspondent | Jennifer Portugal KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 2001-08-02 |
| Decision Date | 2001-10-16 |
| Summary: | summary |