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.

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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

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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