CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353

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 Capd Transfer Set For Reduced Fill Volumes 5c4353.

Pre-market Notification Details

Device IDK852678
510k NumberK852678
Device Name:CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactJulia A Meyer
CorrespondentJulia A Meyer
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-25
Decision Date1985-07-29

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