SONOCA 180/195 WOUND CARE SYSTEM

Instrument, Ultrasonic Surgical

SOERING GMBH

The following data is part of a premarket notification filed by Soering Gmbh with the FDA for Sonoca 180/195 Wound Care System.

Pre-market Notification Details

Device IDK072904
510k NumberK072904
Device Name:SONOCA 180/195 WOUND CARE SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant SOERING GMBH 1600 MANCHESTER WAY Corinth,  TX  76210
ContactCarl Thomas
CorrespondentCarl Thomas
SOERING GMBH 1600 MANCHESTER WAY Corinth,  TX  76210
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-11
Decision Date2008-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250321532612 K072904 000
04250321523535 K072904 000
04250321520008 K072904 000
04250321519989 K072904 000
04250321519965 K072904 000

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