The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Cybersonics Cyberwand Dual Probe Lithotripter.
| Device ID | K052135 |
| 510k Number | K052135 |
| Device Name: | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | CYBERSONICS, INC. 5368 KUHL RD. Erie, PA 16510 -4703 |
| Contact | William A Stoll |
| Correspondent | William A Stoll CYBERSONICS, INC. 5368 KUHL RD. Erie, PA 16510 -4703 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925001428 | K052135 | 000 |