ANCHORAGE CLOSURE DEVICE

Suture, Nonabsorbable, Synthetic, Polyethylene

EPITEK, INC.

The following data is part of a premarket notification filed by Epitek, Inc. with the FDA for Anchorage Closure Device.

Pre-market Notification Details

Device IDK073096
510k NumberK073096
Device Name:ANCHORAGE CLOSURE DEVICE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington,  MN  55437
ContactWerner Hampl
CorrespondentWerner Hampl
EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington,  MN  55437
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-01
Decision Date2008-02-07
Summary:summary

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