QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE

Suture, Surgical, Absorbable, Polydioxanone

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Quill Self-retaining System (srs) Comprised Of Pdo (polydioxanone.

Pre-market Notification Details

Device IDK080680
510k NumberK080680
Device Name:QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon,  VA  20171
ContactTrudy D Estridge
CorrespondentTrudy D Estridge
SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon,  VA  20171
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-10
Decision Date2008-03-21
Summary:summary

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