The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Megapulse Laser System And Fibers.
| Device ID | K090776 |
| 510k Number | K090776 |
| Device Name: | MEGAPULSE LASER SYSTEM AND FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-06-02 |
| Summary: | summary |