The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Millennium Viscous Fluid System.
| Device ID | K972664 |
| 510k Number | K972664 |
| Device Name: | STORZ MILLENNIUM VISCOUS FLUID SYSTEM |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Patrick G Balsmann |
| Correspondent | Patrick G Balsmann STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-10-10 |
| Summary: | summary |