The following data is part of a premarket notification filed by American Mcgaw with the FDA for Capd Exchange Set.
Device ID | K810600 |
510k Number | K810600 |
Device Name: | CAPD EXCHANGE SET |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
Applicant | AMERICAN MCGAW 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-06 |
Decision Date | 1981-03-24 |