The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Vitreous Suction/cutter.
| Device ID | K791000 |
| 510k Number | K791000 |
| Device Name: | VITREOUS SUCTION/CUTTER |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | CONCEPT, INC. 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 | 1979-05-29 |
| Decision Date | 1979-09-04 |