FOLEY-TEMP

Catheter, Urological

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Foley-temp.

Pre-market Notification Details

Device IDK831567
510k NumberK831567
Device Name:FOLEY-TEMP
ClassificationCatheter, Urological
Applicant MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-16
Decision Date1983-08-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521078062 K831567 000
30884521826414 K831567 000
20884521826424 K831567 000
30884521826438 K831567 000
20884521826448 K831567 000
20884521826455 K831567 000
10884521077584 K831567 000
20884521077598 K831567 000
10884521078017 K831567 000
20884521078021 K831567 000
10884521078031 K831567 000
20884521826400 K831567 000

Trademark Results [FOLEY-TEMP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FOLEY-TEMP
FOLEY-TEMP
73457451 not registered Dead/Abandoned
Mallinckrodt, Inc.
1983-12-16

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