The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Storz Modulith, Model Slx-f2.
Device ID | K040476 |
510k Number | K040476 |
Device Name: | STORZ MODULITH, MODEL SLX-F2 |
Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Renate A Maclaren |
Correspondent | Renate A Maclaren 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 | 2004-02-24 |
Decision Date | 2004-08-26 |
Summary: | summary |