The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demediox Barbed Absorbable Surgical Suture.
Device ID | K191361 |
510k Number | K191361 |
Device Name: | DemeDIOX Barbed Absorbable Surgical Suture |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | DemeTECH Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
Contact | Tracy Chadwrick |
Correspondent | Tracy Chadwrick DemeTECH Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-21 |
Decision Date | 2019-11-07 |