The following data is part of a premarket notification filed by Autosafe-reflex Inc. with the FDA for Autosafe-reflex Safety Huber Infusion Set, Autosafe Advantage Safety Huber Infusion Set.
| Device ID | K090117 |
| 510k Number | K090117 |
| Device Name: | AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | AUTOSAFE-REFLEX INC. 1025 NINE N. DR. SUITE K Alpharetta, GA 30004 |
| Contact | John Stephens |
| Correspondent | John Stephens AUTOSAFE-REFLEX INC. 1025 NINE N. DR. SUITE K Alpharetta, GA 30004 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-09-29 |