The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Infuset W/huber Needle.
| Device ID | K844313 |
| 510k Number | K844313 |
| Device Name: | INFUSET W/HUBER NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDFUSION SYSTEMS, INC. 1250 POWERS FERRY RD. Marietta, GA 30067 |
| Contact | William D Arthur |
| Correspondent | William D Arthur MEDFUSION SYSTEMS, INC. 1250 POWERS FERRY RD. Marietta, GA 30067 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-06 |
| Decision Date | 1985-01-22 |