The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (sono).
| Device ID | K011065 |
| 510k Number | K011065 |
| Device Name: | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-05-09 |