The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Neuro-endoscope System By Hopf, Existing Of: Endoscopes, Sheaths, Working Elements, Bipolar And Unipolar Electrodes.
| Device ID | K031858 |
| 510k Number | K031858 |
| Device Name: | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES |
| Classification | Endoscope, Neurological |
| 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 | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2004-07-29 |
| Summary: | summary |