The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Formed-extension Mahurkar Dual Lumen Cath.
| Device ID | K880583 |
| 510k Number | K880583 |
| Device Name: | MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Randy Walls |
| Correspondent | Randy Walls QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-02-22 |