The following data is part of a premarket notification filed by Cooper Medical Corp. with the FDA for Argon Laser Sys-model 5000.
| Device ID | K832703 |
| 510k Number | K832703 |
| Device Name: | ARGON LASER SYS-MODEL 5000 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COOPER MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-11 |
| Decision Date | 1984-01-30 |