The following data is part of a premarket notification filed by Venetec Intl., Inc. with the FDA for Iv Administration Sets With Needle Access Devices.
| Device ID | K980994 |
| 510k Number | K980994 |
| Device Name: | IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES |
| Classification | Set, Administration, Intravascular |
| Applicant | VENETEC INTL., INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Anita Pelletier |
| Correspondent | Anita Pelletier VENETEC INTL., INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-05-29 |