The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Med-logics Microkeratome Blade, Model 7020clb.
| Device ID | K022716 |
| 510k Number | K022716 |
| Device Name: | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB |
| Classification | Keratome, Ac-powered |
| Applicant | MED-LOGICS, INC. 26061 MERIT CIRCLE, SUITE #102 Laguna Hills, CA 92653 |
| Contact | Mark Moyer |
| Correspondent | Mark Moyer 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 | 2002-08-15 |
| Decision Date | 2002-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850724001407 | K022716 | 000 |
| 00850724001315 | K022716 | 000 |
| 00850724001216 | K022716 | 000 |
| 00850724001124 | K022716 | 000 |
| 00850724001117 | K022716 | 000 |
| 00850724001025 | K022716 | 000 |