The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Core Nova Complete Operating Room Endoscopy.
| Device ID | K151282 |
| 510k Number | K151282 |
| Device Name: | Core Nova Complete Operating Room Endoscopy |
| Classification | Endoscopic Central Control Unit |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 -3110 |
| Contact | Michele Mcdonald |
| Correspondent | Lisa Williams RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Parkway Vernon Hills, IL 60061 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2016-01-12 |
| Summary: | summary |