CAPD EXCHANGE SET

Set, Administration, For Peritoneal Dialysis, Disposable

AMERICAN MCGAW

The following data is part of a premarket notification filed by American Mcgaw with the FDA for Capd Exchange Set.

Pre-market Notification Details

Device IDK810600
510k NumberK810600
Device Name:CAPD EXCHANGE SET
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant AMERICAN MCGAW 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-06
Decision Date1981-03-24

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