The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Paradigm Quick-set Ii And Quick-set Ii Subcutaneous Infusion Sets.
| Device ID | K070430 |
| 510k Number | K070430 |
| Device Name: | PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
| Contact | John M Lindskog |
| Correspondent | John M Lindskog UNOMEDICAL A/S AAHOLMVEJ 1-3, OSTED Roskilde, DK Dk-4000 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-13 |
| Decision Date | 2007-04-04 |
| Summary: | summary |