The following data is part of a premarket notification filed by Valnet Medical Corp. with the FDA for Colorvees Iv Set 20 Drops/ml 105, 60 Drops/ml 105, Vented 20 Drops 105, Vented 60 Drops 105.
| Device ID | K983411 |
| 510k Number | K983411 |
| Device Name: | COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 |
| Classification | Set, Administration, Intravascular |
| Applicant | VALNET MEDICAL CORP. B ST., FELICIA INDUSTRIAL PARK (PLAYA) LOT #16 Santa Isabel, PR 00757 -0859 |
| Contact | Victor M Ortiz Medina |
| Correspondent | Victor M Ortiz Medina VALNET MEDICAL CORP. B ST., FELICIA INDUSTRIAL PARK (PLAYA) LOT #16 Santa Isabel, PR 00757 -0859 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-28 |
| Decision Date | 1999-02-09 |
| Summary: | summary |