The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Mid Labs Autonomous Vit Enhancer (ave).
| Device ID | K020911 |
| 510k Number | K020911 |
| Device Name: | MID LABS AUTONOMOUS VIT ENHANCER (AVE) |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. San Leandro, CA 94577 |
| Contact | Linda M Upton |
| Correspondent | Linda M Upton MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. 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 | 2002-03-20 |
| Decision Date | 2002-04-29 |
| Summary: | summary |