SUTURTEK FASTCLOSE SUTURING DEVICE

Suture, Absorbable, Natural

SUTURTEK INCORPORATED

The following data is part of a premarket notification filed by Suturtek Incorporated with the FDA for Suturtek Fastclose Suturing Device.

Pre-market Notification Details

Device IDK030227
510k NumberK030227
Device Name:SUTURTEK FASTCLOSE SUTURING DEVICE
ClassificationSuture, Absorbable, Natural
Applicant SUTURTEK INCORPORATED 7 TIFFANY TRAIL Hopkinton,  MA  01748
ContactDebbie Iampietro
CorrespondentDebbie Iampietro
SUTURTEK INCORPORATED 7 TIFFANY TRAIL Hopkinton,  MA  01748
Product CodeGAL  
CFR Regulation Number878.4830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-22
Decision Date2003-03-17
Summary:summary

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