AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)

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 Automatic Peritoneal Dialysis Cycler Set (5c4437).

Pre-market Notification Details

Device IDK873984
510k NumberK873984
Device Name:AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
ContactRobert L Wilkinson
CorrespondentRobert L Wilkinson
TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-30
Decision Date1987-10-20

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