The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Ssc's Pcl Monofilament Sas, Violet, Coated, Model Tbd.
| Device ID | K003015 |
| 510k Number | K003015 |
| Device Name: | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD |
| Classification | Suture, Absorbable, Synthetic |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Vikki M Hoffman |
| Correspondent | Vikki M Hoffman SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAN |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-27 |
| Decision Date | 2000-12-15 |