The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Acute Peritoneal Dialysis Kit.
Device ID | K870472 |
510k Number | K870472 |
Device Name: | ACUTE PERITONEAL DIALYSIS KIT |
Classification | Catheter, Peritoneal Dialysis, Single Use |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Janet L Morris |
Correspondent | Janet L Morris QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | FKO |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-03 |
Decision Date | 1987-02-25 |