The following data is part of a premarket notification filed by Integra Biotechnical Llc. with the FDA for I.v. Extension Set Or I.v. Administration Set.
| Device ID | K983073 |
| 510k Number | K983073 |
| Device Name: | I.V. EXTENSION SET OR I.V. ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | INTEGRA BIOTECHNICAL LLC. 105 COPPERWOOD WAY, SUITE A Oceanside, CA 92054 |
| Contact | William Bergelin |
| Correspondent | William Bergelin INTEGRA BIOTECHNICAL LLC. 105 COPPERWOOD WAY, SUITE A Oceanside, CA 92054 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1998-12-16 |