The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz/urban Surgical Microscope System.
| Device ID | K844858 |
| 510k Number | K844858 |
| Device Name: | STORZ/URBAN SURGICAL MICROSCOPE SYSTEM |
| Classification | Microscope, Surgical |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Tom Grant |
| Correspondent | Tom Grant STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | EPT |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-14 |
| Decision Date | 1985-03-25 |