The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Ultimate Vit Enhamcer (uve).
| Device ID | K102222 |
| 510k Number | K102222 |
| Device Name: | ULTIMATE VIT ENHAMCER (UVE) |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 557 MC CORMICK STREET San Leandro, CA 94577 |
| Contact | Linda Upton |
| Correspondent | Linda Upton MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 557 MC CORMICK STREET San Leandro, CA 94577 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-06 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812480010994 | K102222 | 000 |
| 10812480010069 | K102222 | 000 |
| 10812480010076 | K102222 | 000 |
| 10812480010083 | K102222 | 000 |
| 10812480010090 | K102222 | 000 |
| 10812480010106 | K102222 | 000 |
| 10812480010113 | K102222 | 000 |
| 10812480010250 | K102222 | 000 |
| 10812480010366 | K102222 | 000 |
| 10812480010434 | K102222 | 000 |
| 10812480010441 | K102222 | 000 |
| 10812480010649 | K102222 | 000 |
| 10812480010656 | K102222 | 000 |
| 10812480010663 | K102222 | 000 |
| 10812480010007 | K102222 | 000 |