TRAVENOL CAPD Y SET 5C4354

Set, Administration, For Peritoneal Dialysis, Disposable

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Travenol Capd Y Set 5c4354.

Pre-market Notification Details

Device IDK853550
510k NumberK853550
Device Name:TRAVENOL CAPD Y SET 5C4354
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactJulia Meyer
CorrespondentJulia Meyer
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-26
Decision Date1985-10-04

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