The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Contour Midface Opposing Uni-directional Threads.
| Device ID | K050548 |
| 510k Number | K050548 |
| Device Name: | CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-02 |
| Decision Date | 2005-04-01 |
| Summary: | summary |