The following data is part of a premarket notification filed by Np Medical, Inc. with the FDA for K100 Neutral Displacement Needle Free Connector.
| Device ID | K130023 |
| 510k Number | K130023 |
| Device Name: | K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | NP MEDICAL, INC. PO BOX 506 South Lyon, MI 48178 |
| Contact | Robert J Bard, Jd, Rac, Cqe |
| Correspondent | Robert J Bard, Jd, Rac, Cqe NP MEDICAL, INC. PO BOX 506 South Lyon, MI 48178 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-03 |
| Decision Date | 2013-04-03 |
| Summary: | summary |