SODIUM CHLORIDE SOLUTION

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

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Sodium Chloride Solution.

Pre-market Notification Details

Device IDK903347
510k NumberK903347
Device Name:SODIUM CHLORIDE SOLUTION
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
ContactMaureen G Mccabe
CorrespondentMaureen G Mccabe
SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-25
Decision Date1990-12-13

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