The following data is part of a premarket notification filed by Med-logics, Inc. with the FDA for Ml Universal Tubing.
| Device ID | K983448 |
| 510k Number | K983448 |
| Device Name: | ML UNIVERSAL TUBING |
| Classification | Tubing, Replacement, Phacofragmentation Unit |
| Applicant | MED-LOGICS, INC. 30251 GOLDEN LANTERN SUITE E-207 Laguna Niguel, CA 92677 |
| Contact | Betty Ross |
| Correspondent | Betty Ross MED-LOGICS, INC. 30251 GOLDEN LANTERN SUITE E-207 Laguna Niguel, CA 92677 |
| Product Code | MSR |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-12-18 |