The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Millennium Microsurgicl System High Speed Vitrectomy System.
| Device ID | K980488 |
| 510k Number | K980488 |
| Device Name: | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Gary M Rauvola |
| Correspondent | Gary M Rauvola STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-03-23 |
| Summary: | summary |