The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Iv Filter Extension Set.
| Device ID | K860803 |
| 510k Number | K860803 |
| Device Name: | IV FILTER EXTENSION SET |
| Classification | Filter, Infusion Line |
| Applicant | MEDFUSION SYSTEMS, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
| Contact | William D Arthur |
| Correspondent | William D Arthur MEDFUSION SYSTEMS, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688510981 | K860803 | 000 |
| 50351688510967 | K860803 | 000 |
| 50351688510950 | K860803 | 000 |
| 50351688507479 | K860803 | 000 |
| 50351688507462 | K860803 | 000 |
| 50351688507455 | K860803 | 000 |