The following data is part of a premarket notification filed by Novosci Corp. with the FDA for D-line Catheter St, Double Lumen St; Extra Flow.
| Device ID | K063355 |
| 510k Number | K063355 |
| Device Name: | D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. The Woodlands, TX 77381 -3902 |
| Contact | David Makanani |
| Correspondent | David Makanani NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. The Woodlands, TX 77381 -3902 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-07 |
| Decision Date | 2007-07-27 |
| Summary: | summary |