STERILE WATER SOLUTION CATALOG # 10000

Catheter And Tip, Suction

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Sterile Water Solution Catalog # 10000.

Pre-market Notification Details

Device IDK904216
510k NumberK904216
Device Name:STERILE WATER SOLUTION CATALOG # 10000
ClassificationCatheter And Tip, Suction
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 CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-12
Decision Date1990-11-16

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