The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Storz Slx-f2 Storm Touch.
| Device ID | K070579 |
| 510k Number | K070579 |
| Device Name: | STORZ SLX-F2 STORM TOUCH |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Paul S Lee |
| Correspondent | Paul S Lee 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-01 |
| Decision Date | 2007-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630039100919 | K070579 | 000 |