The following data is part of a premarket notification filed by Medfusion Systems, Inc. with the FDA for Bag Spike Extension Set.
| Device ID | K863814 |
| 510k Number | K863814 |
| Device Name: | BAG SPIKE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDFUSION SYSTEMS, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
| Contact | Ruffin Booth |
| Correspondent | Ruffin Booth MEDFUSION SYSTEMS, INC. 3070 BUSINESS PARK DR. Norcross, GA 30071 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-10-14 |