The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Quill Self-retaining System (srs) Comprised Of Polydioxanone (pdo).
| Device ID | K080985 |
| 510k Number | K080985 |
| Device Name: | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon, VA 20171 |
| Contact | Trudy D Estridge |
| Correspondent | Trudy D Estridge SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon, VA 20171 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-04-23 |
| Summary: | summary |