STERILE URETHRAL CATHETER PROCEDURE KITS

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

SUPERIOR HEALTHCARE GROUP, INC.

The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Sterile Urethral Catheter Procedure Kits.

Pre-market Notification Details

Device IDK903340
510k NumberK903340
Device Name:STERILE URETHRAL CATHETER PROCEDURE KITS
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
ContactMaureen Mccabe
CorrespondentMaureen Mccabe
SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland,  RI  02864
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-25
Decision Date1990-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30884521009503 K903340 000

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