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, Cl500 Lid, Dornoch Quad Suction Cart With: Dl2800 Lid, Cl500 Lid.
| Device ID | K133786 |
| 510k Number | K133786 |
| Device Name: | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2014-03-21 |
| Summary: | summary |