The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Endocam Flex Hd Camera System 5521.
| Device ID | K161204 |
| 510k Number | K161204 |
| Device Name: | ENDOCAM Flex HD Camera System 5521 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION 353 CORPORATE WOODS PARKWAY Vernon Hill, IL 60061 |
| Contact | Mike Loiterman |
| Correspondent | Mike Loiterman RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION 353 CORPORATE WOODS PARKWAY Vernon Hill, 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 | 2016-04-28 |
| Decision Date | 2017-01-11 |
| Summary: | summary |