The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml-disposable Pak.
| Device ID | K972522 |
| 510k Number | K972522 |
| Device Name: | ML-DISPOSABLE PAK |
| Classification | Tubing, Replacement, Phacofragmentation Unit |
| Applicant | MED-LOGICS, INC. 27071 CABOT ROAD, SUITE 127 Laguna Hills, CA 92653 |
| Contact | Glenn A Dunki-jacobs |
| Correspondent | Glenn A Dunki-jacobs MED-LOGICS, INC. 27071 CABOT ROAD, SUITE 127 Laguna Hills, CA 92653 |
| Product Code | MSR |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-07 |
| Decision Date | 1997-09-30 |