The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Medlogics Ml 4000, Model 4000.
| Device ID | K002515 |
| 510k Number | K002515 |
| Device Name: | MEDLOGICS ML 4000, MODEL 4000 |
| Classification | Keratome, Ac-powered |
| Applicant | MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 Laguna Niguel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik MED-LOGICS, INC. 30001 GOLDEN LANTERN #334 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 | 2000-08-15 |
| Decision Date | 2001-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850724001244 | K002515 | 000 |
| 10850724001145 | K002515 | 000 |
| 10850724001046 | K002515 | 000 |