The following data is part of a premarket notification filed by Cooper Medical Devices Corp. with the FDA for Ocutome Model 8000.
| Device ID | K791898 |
| 510k Number | K791898 |
| Device Name: | OCUTOME MODEL 8000 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | COOPER MEDICAL DEVICES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-10-30 |