The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Med-logics, Model Ml7090.
Device ID | K033293 |
510k Number | K033293 |
Device Name: | MED-LOGICS, MODEL ML7090 |
Classification | Keratome, Ac-powered |
Applicant | MED-LOGICS, INC. 26061 MERIT CIRCLE, SUITE #102 Laguna Hills, CA 92653 |
Contact | Rod Ross |
Correspondent | Rod Ross MED-LOGICS, INC. 26061 MERIT CIRCLE, SUITE #102 Laguna Hills, CA 92653 |
Product Code | HNO |
CFR Regulation Number | 886.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-14 |
Decision Date | 2004-01-13 |