510(k) K042075
K042075 is an FDA 510(k) premarket notification submitted by Quill Medical, Inc. for the device "QUILL SYNTHETIC ABSORBABLE BARBED SUTURE". The FDA issued a decision of Substantially Equivalent on October 26, 2004. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Quill Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2004
- Date Received
- August 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Absorbable, Polydioxanone
- Device Class
- Class II
- Regulation Number
- 878.4840
- Review Panel
- SU
- Submission Type