The following data is part of a premarket notification filed by Demetech Corp. with the FDA for Demetech Absorbable Surgical Suture Plain & Chromic Gut.
Device ID | K072930 |
510k Number | K072930 |
Device Name: | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT |
Classification | Suture, Absorbable, Natural |
Applicant | DEMETECH CORP. 3530 N.W. 115TH AVE. Miami, FL 33178 |
Contact | A.j. Dimercurio |
Correspondent | A.j. Dimercurio DEMETECH CORP. 3530 N.W. 115TH AVE. Miami, FL 33178 |
Product Code | GAL |
CFR Regulation Number | 878.4830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-16 |
Decision Date | 2008-04-30 |
Summary: | summary |