The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Contour Thread Synthetic Absorbable Pdo Barbed Suture.
| Device ID | K053380 |
| 510k Number | K053380 |
| Device Name: | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-01-18 |
| Summary: | summary |