The following data is part of a premarket notification filed by Vision Care Devices, Inc. with the FDA for I/a Vitrophage Model Ypr 2001.
| Device ID | K904909 |
| 510k Number | K904909 |
| Device Name: | I/A VITROPHAGE MODEL YPR 2001 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Contact | Chet Cracchiolo |
| Correspondent | Chet Cracchiolo VISION CARE DEVICES, INC. 1246 REDWOOD BLVD. Redding, CA 96003 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-31 |
| Decision Date | 1991-01-28 |