The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Huber Infusion, Excel Huber Needle.
| Device ID | K113469 |
| 510k Number | K113469 |
| Device Name: | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-22 |
| Decision Date | 2012-10-18 |
| Summary: | summary |