The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Operating Laparoscope, 10-5 Mm, Angeled, Operating Laparoscope 12-7mm, Angled, Operating Laparoscope, 10-5,,. Oblique, D.
| Device ID | K991718 |
| 510k Number | K991718 |
| Device Name: | OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-20 |
| Decision Date | 1999-08-12 |
| Summary: | summary |