The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for The Richard Wolf Endocam Logic Hd Camera System 5525.
| Device ID | K130423 |
| 510k Number | K130423 |
| Device Name: | THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-20 |
| Decision Date | 2013-04-03 |
| Summary: | summary |