The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Sios-interface For Auto Light Projector, Sios-interface For 3 Ccd Endocam, Sios-interface For Laparo Co2 Insufflator.
| Device ID | K002328 |
| 510k Number | K002328 |
| Device Name: | SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR |
| Classification | Insufflator, Laparoscopic |
| 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 | HIF |
| Subsequent Product Code | FWF |
| Subsequent Product Code | GCT |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2001-08-27 |