CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY

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

CYPRESS MEDICAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Cypress Medical Products Catheter (insertion) Tray.

Pre-market Notification Details

Device IDK950092
510k NumberK950092
Device Name:CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry,  IL  60050
ContactKen Rysso
CorrespondentKen Rysso
CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry,  IL  60050
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-10
Decision Date1995-02-27

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