The following data is part of a premarket notification filed by Advanced Bioresearch Assoc. with the FDA for I.v.i.d. Fluid Administration Set Marker.
| Device ID | K944619 |
| 510k Number | K944619 |
| Device Name: | I.V.I.D. FLUID ADMINISTRATION SET MARKER |
| Classification | Set, Administration, Intravascular |
| Applicant | ADVANCED BIORESEARCH ASSOC. 1700 ROCKVILLE PIKE, SUITE 450 Rockville, MD 20852 |
| Contact | Steve Reizler |
| Correspondent | Steve Reizler ADVANCED BIORESEARCH ASSOC. 1700 ROCKVILLE PIKE, SUITE 450 Rockville, MD 20852 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-20 |
| Decision Date | 1995-01-26 |