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 |