The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Nonabsorbable Polypropylene Barbed Suture.
| Device ID | K052373 |
| 510k Number | K052373 |
| Device Name: | QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-30 |
| Decision Date | 2005-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782016973 | K052373 | 000 |
| 10848782016959 | K052373 | 000 |
| 10848782016935 | K052373 | 000 |
| 10848782016911 | K052373 | 000 |
| 10848782016898 | K052373 | 000 |
| 10848782016874 | K052373 | 000 |
| 20705031208206 | K052373 | 000 |
| 20705031208190 | K052373 | 000 |