NIPRO SAFELET CATH

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

NISSHO CORP.

The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Safelet Cath.

Pre-market Notification Details

Device IDK960051
510k NumberK960051
Device Name:NIPRO SAFELET CATH
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant NISSHO CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
ContactLuis Candelario
CorrespondentLuis Candelario
NISSHO CORP. 1384 COPPERFIELD COURT Lexington,  KY  40514 -1268
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-04
Decision Date1996-03-28
Summary:summary

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