CAPD TRANSFER SET SPIKE 5C4363

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 Spike 5c4363.

Pre-market Notification Details

Device IDK860230
510k NumberK860230
Device Name:CAPD TRANSFER SET SPIKE 5C4363
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 Received1986-01-22
Decision Date1986-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.