The following data is part of a premarket notification filed by Surgical Mechanical Research, Inc. with the FDA for System 1 Instrument Stand.
| Device ID | K803195 |
| 510k Number | K803195 |
| Device Name: | SYSTEM 1 INSTRUMENT STAND |
| Classification | Stand, Instrument, Ac-powered, Ophthalmic |
| Applicant | SURGICAL MECHANICAL RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HMF |
| CFR Regulation Number | 886.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-16 |
| Decision Date | 1981-02-04 |