The following data is part of a premarket notification filed by Unomedical A/s with the FDA for I-port Advance Injection Port.
| Device ID | K120337 |
| 510k Number | K120337 |
| Device Name: | I-PORT ADVANCE INJECTION PORT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3 Osted, Lejre, DK 4320 |
| Contact | Soren Melsted |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-02-16 |
| Summary: | summary |