GAMMA STERIL. CAPILLARY FLOW DIALY-G15

System, Dialysate Delivery, Central Multiple Patient

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Gamma Steril. Capillary Flow Dialy-g15.

Pre-market Notification Details

Device IDK832663
510k NumberK832663
Device Name:GAMMA STERIL. CAPILLARY FLOW DIALY-G15
ClassificationSystem, Dialysate Delivery, Central Multiple Patient
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKQ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-08
Decision Date1983-09-12

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