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 |