FDA 510(k) K042075, QUILL SYNTHETIC ABSORBABLE BARBED SUTURE, by Quill Medical, Inc.
FDA 510(k) K042075, QUILL SYNTHETIC ABSORBABLE BARBED SUTURE, by Quill Medical, Inc.
Device Classification Name: Suture, Surgical, Absorbable, Polydioxanone
510(k) Number: K042075
Device Name: QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
Applicant: Quill Medical, Inc.
Regulation Number: 878.484
Classification Product Code: NEW
Date Received: 2004-08-02
Decision Date: 2004-10-26
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 372
Fully redacted pages: 232
Content pages: 140
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