DELTA-A.V. FISTULA CANNULATION SET

Needle, Fistula

AMISCO TRADING CORP.

The following data is part of a premarket notification filed by Amisco Trading Corp. with the FDA for Delta-a.v. Fistula Cannulation Set.

Pre-market Notification Details

Device IDK812621
510k NumberK812621
Device Name:DELTA-A.V. FISTULA CANNULATION SET
ClassificationNeedle, Fistula
Applicant AMISCO TRADING CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-15
Decision Date1981-09-24

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