KOALA CLAMP, KOALA CLAMP AND CUTTER

Clamp, Umbilical

MATERNUS, INC.

The following data is part of a premarket notification filed by Maternus, Inc. with the FDA for Koala Clamp, Koala Clamp And Cutter.

Pre-market Notification Details

Device IDK011621
510k NumberK011621
Device Name:KOALA CLAMP, KOALA CLAMP AND CUTTER
ClassificationClamp, Umbilical
Applicant MATERNUS, INC. P.O. BOX 782089 San Antonio,  TX  78278
ContactRonald B Hicks
CorrespondentRonald B Hicks
MATERNUS, INC. P.O. BOX 782089 San Antonio,  TX  78278
Product CodeHFW  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-25
Decision Date2001-08-10
Summary:summary

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