The following data is part of a premarket notification filed by Imed Corp. with the FDA for Vented/non-vented Gemini Administration Set.
| Device ID | K944320 |
| 510k Number | K944320 |
| Device Name: | VENTED/NON-VENTED GEMINI ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Contact | Ahmad Sajadi |
| Correspondent | Ahmad Sajadi IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1995-02-14 |