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 |