The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for 3 Ccd Endocam 5550.
| Device ID | K080977 |
| 510k Number | K080977 |
| Device Name: | 3 CCD ENDOCAM 5550 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Niels Schmidt |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-05-14 |
| Summary: | summary |