The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Extension Set W/injection Site.
| Device ID | K842984 |
| 510k Number | K842984 |
| Device Name: | EXTENSION SET W/INJECTION SITE |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-10-16 |