The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Mini Trocar Sleeve And Trocars 3.5 Mm, Micro Trocar Sleeve And Trocars 2 Mm, Dilatation Sleeve And Guide Rod 2 Mm To 3.m.
| Device ID | K973737 |
| 510k Number | K973737 |
| Device Name: | MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| 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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1997-12-12 |
| Summary: | summary |