UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

System, Peritoneal, Automatic Delivery

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Upgraded Auto Peritoneal Dialysis Cycler System.

Pre-market Notification Details

Device IDK872652
510k NumberK872652
Device Name:UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
ClassificationSystem, Peritoneal, Automatic Delivery
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 CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-07
Decision Date1987-09-30

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