The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml Disposable Alk Tubing.
| Device ID | K971173 |
| 510k Number | K971173 |
| Device Name: | ML DISPOSABLE ALK TUBING |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | MED-LOGICS, INC. 27071 CABOT ROAD, SUITE 127 Laguna Hills, CA 92653 |
| Contact | Rod Ross |
| Correspondent | Rod Ross MED-LOGICS, INC. 27071 CABOT ROAD, SUITE 127 Laguna Hills, CA 92653 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-05-22 |