The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Modulth Slk.
| Device ID | K120769 |
| 510k Number | K120769 |
| Device Name: | MODULTH SLK |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Leigh Spotten |
| Correspondent | Leigh Spotten KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039100278 | K120769 | 000 |
| 07630039100902 | K120769 | 000 |