The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Supra-vit(tm).
Device ID | K932669 |
510k Number | K932669 |
Device Name: | SUPRA-VIT(TM) |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Contact | Erik W Peterson |
Correspondent | Erik W Peterson MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 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 | 1993-06-02 |
Decision Date | 1994-06-03 |