QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

Suture, Surgical, Absorbable, Polydioxanone

QUILL MEDICAL, INC.

The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Synthetic Absorbable Barbed Suture.

Pre-market Notification Details

Device IDK051609
510k NumberK051609
Device Name:QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park,  NC  27713
ContactLois V Smart
CorrespondentLois V Smart
QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park,  NC  27713
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-17
Decision Date2005-08-04
Summary:summary

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