The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Hystero Co2-pneu 2221.
| Device ID | K964136 |
| 510k Number | K964136 |
| Device Name: | HYSTERO CO2-PNEU 2221 |
| Classification | Insufflator, Hysteroscopic |
| 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 | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-01-10 |
| Summary: | summary |