The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Monoderm Surgical Suture.
| Device ID | K140227 |
| 510k Number | K140227 |
| Device Name: | MONODERM SURGICAL SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Kirsten Stowell Franco |
| Correspondent | Kirsten Stowell Franco SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-02-28 |
| Summary: | summary |