The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Nonabsorbable Nylon Barbed Suture.
| Device ID | K052900 |
| 510k Number | K052900 |
| Device Name: | QUILL NONABSORBABLE NYLON BARBED SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park, NC 27713 |
| Contact | Lois V Smart |
| Correspondent | Lois V Smart QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park, NC 27713 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2005-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782011084 | K052900 | 000 |
| 10848782011077 | K052900 | 000 |