QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

QUILL MEDICAL, INC.

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

Pre-market Notification Details

Device IDK052373
510k NumberK052373
Device Name:QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park,  NC  27713
ContactLois V Smart
CorrespondentLois V Smart
QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park,  NC  27713
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-30
Decision Date2005-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782016973 K052373 000
10848782016959 K052373 000
10848782016935 K052373 000
10848782016911 K052373 000
10848782016898 K052373 000
10848782016874 K052373 000
20705031208206 K052373 000
20705031208190 K052373 000

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