The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demetech Demediox Absorbable Surgical Suture.
Device ID | K181582 |
510k Number | K181582 |
Device Name: | DemeTECH DemeDIOX Absorbable Surgical Suture |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | Demetech Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
Contact | Linda Hernandez |
Correspondent | Linda Hernandez Demetech Corporation 14175 NW 60th Ave Miami Lakes, FL 33014 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-15 |
Decision Date | 2018-08-27 |
Summary: | summary |