The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Synthetic Absorbable Barbed Suture.
| Device ID | K051609 |
| 510k Number | K051609 |
| Device Name: | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park, NC 27713 |
| Contact | Lois V Smart |
| Correspondent | Lois V Smart QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park, NC 27713 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-08-04 |
| Summary: | summary |