Self-retaining Retractor

Retractor, Self-retaining, For Neurosurgery

FETZER MEDICAL GMBH & CO.KG

The following data is part of a premarket notification filed by Fetzer Medical Gmbh & Co.kg with the FDA for Self-retaining Retractor.

Pre-market Notification Details

Device IDK161004
510k NumberK161004
Device Name:Self-retaining Retractor
ClassificationRetractor, Self-retaining, For Neurosurgery
Applicant FETZER MEDICAL GMBH & CO.KG UNTER BUCHSTEIG 5 Tuttlingen,  DE 78532
ContactHarald Jung
CorrespondentHarald Jung
FETZER MEDICAL GMBH & CO.KG UNTER BUCHSTEIG 5 Tuttlingen,  DE 78532
Product CodeGZT  
CFR Regulation Number882.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-11
Decision Date2016-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887482175576 K161004 000
00887482105337 K161004 000
00887482105320 K161004 000
00887482105313 K161004 000
00887482105306 K161004 000
00887482104545 K161004 000
00887482056462 K161004 000

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