The following data is part of a premarket notification filed by Y with the FDA for Ivac Vented Syringe Adapter Administration Sets.
| Device ID | K934095 |
| 510k Number | K934095 |
| Device Name: | IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
| Contact | Jennifer S Hankard |
| Correspondent | Jennifer S Hankard Y P.O. BOX 85335 San Diego, CA 92138 -5335 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403422247 | K934095 | 000 |
| 50885403233232 | K934095 | 000 |
| 50885403232600 | K934095 | 000 |
| 37613203012547 | K934095 | 000 |