The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Disposable Stopcocks, Models 3w-rc. Ncn-3, 3w-r, 3w-l.
| Device ID | K041779 |
| 510k Number | K041779 |
| Device Name: | NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L |
| Classification | Stopcock, I.v. Set |
| 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 | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-01 |
| Decision Date | 2004-09-21 |
| Summary: | summary |