The following data is part of a premarket notification filed by Ab2 Medical Products, Llp with the FDA for Ab2 Med-flo Solution Set.
| Device ID | K984569 |
| 510k Number | K984569 |
| Device Name: | AB2 MED-FLO SOLUTION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | AB2 MEDICAL PRODUCTS, LLP 52 BUTTONBUSH CT. The Woodlands, TX 77380 -0926 |
| Contact | Arthur Chandler,iii |
| Correspondent | Arthur Chandler,iii AB2 MEDICAL PRODUCTS, LLP 52 BUTTONBUSH CT. The Woodlands, TX 77380 -0926 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-08-12 |