CAPD - CATHETER ADAPTER

System, Peritoneal, Automatic Delivery

AMERICAN MCGAW

The following data is part of a premarket notification filed by American Mcgaw with the FDA for Capd - Catheter Adapter.

Pre-market Notification Details

Device IDK831716
510k NumberK831716
Device Name:CAPD - CATHETER ADAPTER
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant AMERICAN MCGAW 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-27
Decision Date1983-06-24

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