GAMMA STERILIZED CAPILLARY FLOW DIALYZ

Accessories, Blood Circuit, Hemodialysis

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Gamma Sterilized Capillary Flow Dialyz.

Pre-market Notification Details

Device IDK823778
510k NumberK823778
Device Name:GAMMA STERILIZED CAPILLARY FLOW DIALYZ
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-15
Decision Date1983-01-07

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