The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml Blade, Model Ml7030.
| Device ID | K010872 |
| 510k Number | K010872 |
| Device Name: | ML BLADE, MODEL ML7030 |
| Classification | Keratome, Ac-powered |
| Applicant | MED-LOGICS, INC. 27881 LA PAZ #G316 Laguna Niguel,, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik MED-LOGICS, INC. 27881 LA PAZ #G316 Laguna Niguel,, CA 92677 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850724001339 | K010872 | 000 |
| 00850724001322 | K010872 | 000 |
| 00850724001230 | K010872 | 000 |
| 00850724001223 | K010872 | 000 |
| 00850724001131 | K010872 | 000 |
| 00850724001032 | K010872 | 000 |