CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186

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 Disconnect System 5c4182, 5c4183, 5c4186.

Pre-market Notification Details

Device IDK860700
510k NumberK860700
Device Name:CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
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 Received1986-02-25
Decision Date1986-04-07

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