The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Hypodermic Needle.
| Device ID | K013293 |
| 510k Number | K013293 |
| Device Name: | NIPRO HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Contact | Kaelyn B Hadley |
| Correspondent | Kaelyn B Hadley NIPRO MEDICAL CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-02 |
| Decision Date | 2001-12-14 |
| Summary: | summary |