EXTENDED LIFE CAPD SOLUTION TRANSFER

System, Peritoneal, Automatic Delivery

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Extended Life Capd Solution Transfer.

Pre-market Notification Details

Device IDK842885
510k NumberK842885
Device Name:EXTENDED LIFE CAPD SOLUTION TRANSFER
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant TRAVENOL LABORATORIES, S.A. Deerfield ,  IL  60015 -
ContactJulia A Meyer
CorrespondentJulia A Meyer
TRAVENOL LABORATORIES, S.A. Deerfield ,  IL  60015 -
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-23
Decision Date1984-10-18

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