The following data is part of a premarket notification filed by Dornoch Medical Systems, Inc. with the FDA for Dornoch Duo Suction Cart With Dl2800 Lid Model Ul-du2800, Dornoch Duo Suction Cart With Cl500 Lid Model Ul-du500, Dornoc.
| Device ID | K123188 |
| 510k Number | K123188 |
| Device Name: | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | DORNOCH MEDICAL SYSTEMS, INC. 200 Nw Parkway Rd Riverside, MO 64150 |
| Contact | Larry Smith |
| Correspondent | Larry Smith DORNOCH MEDICAL SYSTEMS, INC. 200 Nw Parkway Rd Riverside, MO 64150 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2013-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024465916 | K123188 | 000 |
| 00889024465909 | K123188 | 000 |
| 00889024465855 | K123188 | 000 |
| 00889024465848 | K123188 | 000 |
| 00889024465824 | K123188 | 000 |
| 00889024465817 | K123188 | 000 |
| 00889024465800 | K123188 | 000 |