The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Universal Operating Hysteriscope Set By Solima-zupi, Consisting Of Optic, Inner And Outer Sheaths, Forceps, Model 8753.
| Device ID | K033113 |
| 510k Number | K033113 |
| Device Name: | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-12-23 |
| Summary: | summary |