The following data is part of a premarket notification filed by Dornoch Medical Systems, Inc. with the FDA for Transposal Ultra Systems.
| Device ID | K081047 |
| 510k Number | K081047 |
| Device Name: | TRANSPOSAL ULTRA SYSTEMS |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | DORNOCH MEDICAL SYSTEMS, INC. 4032 WEST RIVERSIDE ST. Riverside, MO 64150 |
| Contact | Anthony Martini |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024471269 | K081047 | 000 |
| 00889024465800 | K081047 | 000 |
| 00889024465817 | K081047 | 000 |
| 00889024465824 | K081047 | 000 |
| 00889024465831 | K081047 | 000 |
| 00889024465848 | K081047 | 000 |
| 00889024465855 | K081047 | 000 |
| 00889024465909 | K081047 | 000 |
| 00889024465916 | K081047 | 000 |
| 00889024471221 | K081047 | 000 |
| 00889024471214 | K081047 | 000 |
| 00889024465794 | K081047 | 000 |