The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Model 2231 Co2 Insufflator.
| Device ID | K934884 |
| 510k Number | K934884 |
| Device Name: | MODEL 2231 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 |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1995-02-07 |