The following data is part of a premarket notification filed by Trek Medical Products, Inc. with the FDA for Ves-10 Intraocular Scissors Drive.
| Device ID | K864035 |
| 510k Number | K864035 |
| Device Name: | VES-10 INTRAOCULAR SCISSORS DRIVE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | TREK MEDICAL PRODUCTS, INC. 2208 SOUTH 38TH ST. Milwaukee, WI 53215 |
| Contact | Kevin B Sinnett |
| Correspondent | Kevin B Sinnett TREK MEDICAL PRODUCTS, INC. 2208 SOUTH 38TH ST. Milwaukee, WI 53215 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-16 |
| Decision Date | 1986-12-15 |