The following data is part of a premarket notification filed by K.e.p., Llc with the FDA for K.e.p. Connector And Clip.
| Device ID | K042900 |
| 510k Number | K042900 |
| Device Name: | K.E.P. CONNECTOR AND CLIP |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | K.E.P., LLC 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson K.E.P., LLC 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-19 |
| Decision Date | 2004-11-05 |
| Summary: | summary |