The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Coreless Needle/coreless Needle Set.
| Device ID | K971582 |
| 510k Number | K971582 |
| Device Name: | NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 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 | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-30 |
| Decision Date | 1997-12-22 |
| Summary: | summary |