The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Pvc Empty Solution Container W/3 Lead Transfer Set.
| Device ID | K890095 |
| 510k Number | K890095 |
| Device Name: | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET |
| Classification | Container, I.v. |
| Applicant | KELLS MEDICAL, INC. 1518 - CONESTOGA COURT Redlands, CA 92373 |
| Contact | Charles M Grey |
| Correspondent | Charles M Grey KELLS MEDICAL, INC. 1518 - CONESTOGA COURT Redlands, CA 92373 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-05-24 |