The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Cysto-urethroscopes E-line Existing Of: Sheaths, Obturators, Inserts, Attchements, And Forceps Model 8650, 8652, 8660.
| Device ID | K011496 |
| 510k Number | K011496 |
| Device Name: | CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 |
| Classification | Cystourethroscope |
| 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 | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2001-08-10 |
| Summary: | summary |