The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Sa.ef(tm) Infusion Port Ii - Connector And Extension Set.
| Device ID | K964876 |
| 510k Number | K964876 |
| Device Name: | SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | VLV ASSOCIATES, INC. 30-C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | Vincent Vaillancourt |
| Correspondent | Vincent Vaillancourt VLV ASSOCIATES, INC. 30-C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-05 |
| Decision Date | 1997-02-28 |