The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Vitre Con.
Device ID | K820026 |
510k Number | K820026 |
Device Name: | VITRE CON |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-05 |
Decision Date | 1982-02-05 |